Multi-factor control of ear stimulation

ABSTRACT

Systems and related methods for controlling an ear stimulation device with a personal computing device are described. Multiple factors, including a mood of the user, a user control input, and a secondary factor input are used in controlling the ear stimulation device. Secondary factors include, a variety of factors relating to or influencing the state of the user, including but not limited to, environmental conditions, sleep, diet, or various activities of the user. User inputs can be open-ended or selected from a menu, for example. In an aspect, a correlation module correlates mood of the user to other factors, and control of stimulation is based thereon. In various aspects, the system is also responsive to inputs from sensors or computing networks. In an aspect, the earpiece delivers an audio output such as music from an audio player.

If an Application Data Sheet (ADS) has been filed on the filing date ofthis application, it is incorporated by reference herein. Anyapplications claimed on the ADS for priority under 35 U.S.C. §§ 119,120, 121, or 365(c), and any and all parent, grandparent,great-grandparent, etc. applications of such applications, are alsoincorporated by reference, including any priority claims made in thoseapplications and any material incorporated by reference, to the extentsuch subject matter is not inconsistent herewith.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of the earliest availableeffective filing date(s) from the following listed application(s) (the“Priority Applications”), if any, listed below (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 USC § 119(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Priority Application(s)).

PRIORITY APPLICATIONS

The present application constitutes a continuation-in-part of U.S.patent application Ser. No. 14/670,504, entitled EAR STIMULATION WITHNEURAL FEEDBACK SENSING, naming RODERICK A. HYDE, MURIEL Y. ISHIKAWA,JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA,NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLESWHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors,filed 27 Mar. 2015, which is currently co-pending or is an applicationof which a currently co-pending application is entitled to the benefitof the filing date.

The present application constitutes a continuation-in-part of U.S.patent application Ser. No. 14/670,537, entitled VIBRATORY EARSTIMULATION SYSTEM AND METHOD, naming RODERICK A. HYDE, MURIEL Y.ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L.MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE,CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, asinventors, filed 27 Mar. 2015, which is currently co-pending or is anapplication of which a currently co-pending application is entitled tothe benefit of the filing date.

The present application constitutes a continuation-in-part of U.S.patent application Ser. No. 14/670,560, entitled METHOD AND SYSTEM FORCONTROLLING EAR STIMULATION, naming RODERICK A. HYDE, MURIEL Y.ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L.MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE,CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, asinventors, filed 27 Mar. 2015, which is currently co-pending or is anapplication of which a currently co-pending application is entitled tothe benefit of the filing date.

The present application constitutes a continuation-in-part of U.S.patent application Ser. No. 14/670,582, entitled USER INTERFACE METHODAND SYSTEM FOR EAR STIMULATION, naming RODERICK A. HYDE, MURIEL Y.ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L.MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE,CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, asinventors, filed 27 Mar. 2015, which is currently co-pending or is anapplication of which a currently co-pending application is entitled tothe benefit of the filing date.

The present application constitutes a continuation-in-part of U.S.patent application Ser. No. 14/670,620, entitled NEURAL STIMULATIONMETHOD AND SYSTEM WITH AUDIO OUTPUT, naming RODERICK A. HYDE, MURIEL Y.ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L.MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE,CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, asinventors, filed 27 Mar. 2015, which is currently co-pending or is anapplication of which a currently co-pending application is entitled tothe benefit of the filing date.

The present application constitutes a continuation-in-part of U.S.patent application Ser. No. 14/670,656, entitled RECOMMENDATION METHODAND SYSTEM FOR TREATMENTS INCLUDING EAR STIMULATION, naming RODERICK A.HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A.MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY,CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIAY. H. WOOD, as inventors, filed 27 Mar. 2015, which is currentlyco-pending or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

The present application constitutes a continuation-in-part of U.S.patent application Ser. No. 15/291,358, entitled NERVE STIMULATIONSYSTEM AND RELATED CONTROLLER, naming RODERICK A. HYDE, MURIEL Y.ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L.MALASKA, NATHAN P. MYHRVOLD, BRITTANY SCHEID, ELIZABETH A. SWEENEY,CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIAY. H. WOOD, as inventors, filed 12 Oct. 2016, which is currentlyco-pending or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

If the listings of applications provided above are inconsistent with thelistings provided via an ADS, it is the intent of the Applicant to claimpriority to each application that appears in the DomesticBenefit/National Stage Information section of the ADS and to eachapplication that appears in the Priority Applications section of thisapplication.

All subject matter of the Priority Applications and of any and allapplications related to the Priority Applications by priority claims(directly or indirectly), including any priority claims made and subjectmatter incorporated by reference therein as of the filing date of theinstant application, is incorporated herein by reference to the extentsuch subject matter is not inconsistent herewith.

SUMMARY

In an aspect, a neural stimulation system includes, but is not limitedto, a neural signal sensor adapted to sense a neural signal from asubject, the neural signal indicative of a physiological status of thesubject, a neural stimulator adapted to produce a stimulus responsive tothe sensed neural signal, the stimulus configured to activate at leastone sensory nerve fiber innervating at least a portion of a pinna of thesubject, and a securing member configured to secure the neuralstimulator to the pinna. In addition to the foregoing, other systemaspects are described in the claims, drawings, and text forming a partof the disclosure set forth herein.

In an aspect, a method includes, but is not limited to, sensing with aneural signal sensor a neural signal indicative of a physiologicalstatus of a subject, the neural signal sensor located in or on a portionof a body of the subject, determining with signal analysis circuitry atleast one parameter of the sensed neural signal, and delivering a neuralstimulus with a neural stimulation device worn on a pinna of the subjectresponsive to the sensed neural signal, wherein the neural stimulus isconfigured to modulate the activity of at least one sensory nerve fiberinnervating at least a portion of the pinna of the subject. In additionto the foregoing, other method aspects are described in the claims,drawings, and text forming a part of the disclosure set forth herein.

A wearable neural stimulation device includes, but is not limited to, avibratory mechanical stimulator adapted to produce a vibratory stimulusof sufficient frequency and amplitude to modulate the activity of atleast one mechanoreceptor with a receptive field on at least a portionof a pinna of a subject, and a securing member configured to secure thevibratory mechanical stimulator to the pinna. In addition to theforegoing, other device aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a method includes, but is not limited to, delivering avibratory mechanical stimulus to at least a portion of a pinna of asubject with a neural stimulation device worn on the pinna of thesubject, wherein the vibratory mechanical stimulus is of sufficientfrequency and amplitude to modulate the activity of at least onemechanoreceptor with a receptive field on the at least a portion of thepinna. In addition to the foregoing, other method aspects are describedin the claims, drawings, and text forming a part of the disclosure setforth herein.

In an aspect, a neural stimulation system includes, but is not limitedto, a wearable neural stimulation device and a personal computingdevice, the wearable neural stimulation device including a neuralstimulator adapted to produce a stimulus for activating at least onesensory nerve fiber innervating at least a portion of a pinna of asubject, a securing member configured to secure the neural stimulator tothe pinna, control circuitry incorporated into the wearable neuralstimulation device for controlling operation of the neural stimulator,and first communication circuitry incorporated into the wearable neuralstimulation device and operatively connected to the control circuitry,the first communication circuitry configured for at least one of sendinga signal to and receiving a signal from a personal computing device; andthe personal computing device including a user interface for at leastone of presenting information to and receiving information from a user,control circuitry operatively connected to the user interface, secondcommunication circuitry configured for at least one of sending a signalto and receiving a signal from the first communication circuitry, andinstructions that when executed on the personal computing device causethe personal computing device to perform at least one of sending asignal to and receiving a signal from the wearable neural stimulationdevice via the second communication circuitry. In addition to theforegoing, other system aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a system includes, but is not limited to, a personalcomputing device comprising circuitry for receiving a neural activitysignal, the neural activity signal indicative of a physiological statusof a subject, circuitry for determining a neural stimulus control signalbased at least in part on the neural activity signal, and circuitry foroutputting the neural stimulus control signal to a neural stimulationdevice including an external neural stimulator configured to be carriedon a pinna of the subject, wherein the neural stimulus control signal isconfigured to control delivery of a neural stimulus by the externalneural stimulator, the neural stimulus configured to activate at leastone sensory nerve fiber innervating at least a portion of the pinna. Inaddition to the foregoing, other system aspects are described in theclaims, drawings, and text forming a part of the disclosure set forthherein.

In an aspect, a method includes, but is not limited to, receiving aneural activity signal at a personal computing device, the neuralactivity signal indicative of a physiological status of a subject,determining a neural stimulus control signal based at least in part onthe neural activity signal, and outputting the neural stimulus controlsignal from the personal computing device to a neural stimulation deviceincluding an external neural stimulator configured to be carried on apinna of the subject, wherein the neural stimulus control signal isconfigured to control delivery of a neural stimulus by the externalneural stimulator, the neural stimulus configured to activate at leastone sensory nerve fiber innervating at least a portion of the pinna. Inaddition to the foregoing, other method aspects are described in theclaims, drawings, and text forming a part of the disclosure set forthherein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for receiving a neural activity signal, the neural activitysignal indicative of a physiological status of a subject, one or moreinstructions for determining a neural stimulus control signal based atleast in part on the neural activity signal, and one or moreinstructions for outputting the neural stimulus control signal to aneural stimulation device including an external neural stimulatorconfigured to be carried on a pinna of the subject, wherein the neuralstimulus control signal is configured to control delivery of a neuralstimulus by the external neural stimulator, the neural stimulusconfigured to activate at least one sensory nerve fiber innervating atleast a portion of the pinna. In addition to the foregoing, otheraspects of a computer program product are described in the claims,drawings, and text forming a part of the disclosure set forth herein.

In an aspect, a method includes, but is not limited to receiving aphysiological activity signal at a personal computing device, thephysiological activity signal indicative of a physiological status of asubject, determining a neural stimulus control signal based at least inpart on the physiological activity signal, outputting the neuralstimulus control signal from the personal computing device to a neuralstimulation device including an external neural stimulator configured tobe carried on a pinna of the subject, wherein the neural stimuluscontrol signal is configured to control delivery of a neural stimulus bythe external neural stimulator, the neural stimulus configured toactivate at least one sensory nerve fiber innervating at least a portionof the pinna, and presenting information to the subject via a userinterface. In addition to the foregoing, other method aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a system includes, but is not limited to a personalcomputing device including circuitry for receiving a physiologicalactivity signal at a personal computing device, the physiologicalactivity signal indicative of a physiological status of a subject,circuitry for determining a neural stimulus control signal based atleast in part on the physiological activity signal, the neural stimuluscontrol signal is configured to control delivery of a neural stimulus bythe external neural stimulator, the neural stimulus configured toactivate at least one sensory nerve fiber innervating at least a portionof the pinna, circuitry for outputting the neural stimulus controlsignal from the personal computing device to a neural stimulation deviceincluding an external neural stimulator configured to be carried on apinna of the subject, and circuitry for presenting information to thesubject via a user interface. In addition to the foregoing, otherpersonal computing device aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for receiving a physiological activity signal, thephysiological activity signal indicative of a physiological status of asubject, one or more instructions for determining a neural stimuluscontrol signal based at least in part on the physiological activitysignal, one or more instructions for outputting the neural stimuluscontrol signal to a neural stimulation device including an externalneural stimulator configured to be carried on an ear of a subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna, and one or moreinstructions for presenting information to the subject via a userinterface. In addition to the foregoing, other computer program productaspects are described in the claims, drawings, and text forming a partof the disclosure set forth herein.

In an aspect, a system includes, but is not limited to a personalcomputing device including circuitry for receiving a physiologicalactivity signal at a personal computing device, the physiologicalactivity signal indicative of a physiological status of a subject,circuitry for determining a neural stimulus control signal based atleast in part on the physiological activity signal, circuitry foroutputting the neural stimulus control signal from the personalcomputing device to a neural stimulation device including an externalneural stimulator configured to be carried on a pinna of the subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna, and circuitry foroutputting an audio output signal via an audio output of the personalcomputing device. In addition to the foregoing, other system aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a method includes, but is not limited to, receiving aphysiological activity signal at a personal computing device, thephysiological activity signal indicative of a physiological status of asubject, determining a neural stimulus control signal based at least inpart on the physiological activity signal, outputting the neuralstimulus control signal from the personal computing device to a neuralstimulation device including an external neural stimulator configured tobe carried on a pinna of the subject, wherein the neural stimuluscontrol signal is configured to control delivery of a neural stimulus bythe external neural stimulator, the neural stimulus configured toactivate at least one sensory nerve fiber innervating at least a portionof the pinna, and outputting an audio output signal via an audio outputof the personal computing device. In addition to the foregoing, othermethod aspects are described in the claims, drawings, and text forming apart of the disclosure set forth herein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for receiving a physiological activity signal at a personalcomputing device, the physiological activity signal indicative of aphysiological status of a subject, one or more instructions fordetermining a neural stimulus control signal based at least in part onthe physiological activity signal, one or more instructions foroutputting the neural stimulus control signal from the personalcomputing device to a neural stimulation device including an externalneural stimulator configured to be carried on a pinna of the subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna, and one or moreinstructions for outputting an audio output signal via an audio outputof the personal computing device. In addition to the foregoing, othercomputer program product aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a method includes, but is not limited to, determining avibratory stimulus control signal with stimulation control circuitry ina personal computing device, and outputting the vibratory stimuluscontrol signal from the personal computing device to a wearablemechanical stimulation device including a vibratory mechanicalstimulator configured to be carried on a pinna of a subject, wherein thevibratory stimulus control signal is configured to control delivery of avibratory stimulus by the vibratory mechanical stimulator, the vibratorystimulus configured to activate at least one mechanoreceptor with areceptive field on at least a portion of the pinna. In addition to theforegoing, other method aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a system includes, but is not limited to, a personalcomputing device including circuitry for determining a vibratorystimulus control signal, and circuitry for outputting the vibratorystimulus control signal to a wearable mechanical stimulation deviceincluding a vibratory mechanical stimulator configured to be carried ona pinna of a subject, wherein the vibratory stimulus control signal isconfigured to control delivery of a vibratory stimulus by the vibratorymechanical stimulator, the vibratory stimulus configured to activate atleast one mechanoreceptor with a receptive field on at least a portionof the pinna. In addition to the foregoing, other system aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for determining a vibratory stimulus control signalconfigured to control delivery of a vibratory stimulus by a vibratorymechanical stimulator, the vibratory stimulus configured to activate atleast one mechanoreceptor with a receptive field on at least a portionof a pinna of a subject, and one or more instructions for outputting thevibratory stimulus control signal to a wearable mechanical stimulationdevice including the least one vibratory mechanical stimulator. Inaddition to the foregoing, other computer program product aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a method includes, but is not limited to, receivingidentifying information at a computing system, the identifyinginformation identifying at least one of a subject and a neuralstimulation device associated with the subject, the neural stimulationdevice configured to be carried on an ear of a subject and including anexternal neural stimulator, and transmitting a recommendation relatingto a treatment regimen from the computing system to a personal computingdevice used by the subject, the treatment regimen including delivery ofa neural stimulus to the subject with the external neural stimulator,the neural stimulus configured to activate at least one sensory nervefiber innervating skin on or in the vicinity of the ear of the subject.In addition to the foregoing, other method aspects are described in theclaims, drawings, and text forming a part of the disclosure set forthherein.

In an aspect, a system includes, but is not limited to, circuitry forreceiving identifying information identifying at least one of a subjectand a neural stimulation device associated with the subject, the neuralstimulation device configured to be carried on an ear of a subject andincluding an external neural stimulator, and circuitry for providing arecommendation relating to a treatment regimen to the subject, thetreatment regimen including delivery of a neural stimulus to the subjectwith the external neural stimulator, the neural stimulus configured toactivate at least one sensory nerve fiber innervating skin on or in thevicinity of the ear of the subject. In addition to the foregoing, othersystem aspects are described in the claims, drawings, and text forming apart of the disclosure set forth herein.

In an aspect, a computer program product includes, but is not limitedto, a non-transitory signal-bearing medium bearing one or moreinstructions for receiving identifying information identifying at leastone of a subject and a neural stimulation device associated with thesubject, the neural stimulation device configured to be carried on anear of a subject and including an external neural stimulator, and one ormore instructions for providing a recommendation relating to a treatmentregimen to the subject, the treatment regimen including delivery of aneural stimulus to the subject with the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating skin on or in the vicinity of the ear of the subject. Inaddition to the foregoing, other computer program product aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a method of controlling an ear stimulation device with apersonal computing device includes, but is not limited to, capturing,with image capture circuitry on the personal computing device, via auser-facing camera associated with the personal computing device, animage of a user of the personal computing device; processing the image,using image processing circuitry on the personal computing device, todetermine at least one parameter; and controlling, with neural stimuluscontrol signal determination circuitry on the personal computing device,based at least in part on the at least one parameter, delivery of astimulus to at least one nerve innervating an ear of the user with theear stimulation device. In a further aspect, the method includesprocessing the image, using the image processing circuitry, to determinethe presence of at least one earpiece of the ear stimulation devicelocated at an ear of the user; the ear of the user at which the at leastone earpiece is located, the ear selected from a right ear of the userand a left ear of the user; and at least one attribute of the at leastone earpiece indicative of usability of the at least one earpiece withone of the left or the right ear of the user; determining, usingapplication software on the personal computing device, the ear at whichthe earpiece is usable, based on the at least one attribute of the atleast one earpiece; determining, using application software on thepersonal computing device, whether the ear at which the at least oneearpiece is located is the ear at which the earpiece is usable; and ifthe ear at which the at least one earpiece is located is not the ear atwhich the earpiece is usable, sending a control signal from the personalcomputing device to the ear stimulation device, under control of theneural stimulus control signal determination circuitry, to preventdelivery of a stimulus to the ear at which the earpiece is located viathe earpiece. In addition to the foregoing, other method aspects aredescribed in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, an ear stimulation device control system includes, but isnot limited to, a personal computing device; a user-facing cameraassociated with the personal computing device; image capture circuitryadapted to capture an image of a user of the personal computing devicefrom the user-facing camera; image processing circuitry configured toprocess the image to determine at least one parameter; and neuralstimulus control signal determination circuitry configured to controldelivery of a stimulus to at least one nerve innervating an ear of theuser with an ear stimulation device, based at least in part on the atleast one parameter. In a further aspect, image processing circuitryincludes an earpiece location module configured to process the image todetermine the presence of at least one earpiece of the ear stimulationdevice located at an ear of the user; the ear of the user at which theat least one earpiece is located, the ear selected from a right ear ofthe user and a left ear of the user; and at least one attribute of theat least one earpiece indicative of usability of the at least oneearpiece with one of the left or the right ear of the user; and theneural stimulus control signal determination circuitry is configured todetermine the ear at which the earpiece is usable, based on the at leastone attribute of the at least one earpiece; determine whether the ear atwhich the at least one earpiece is located is the ear at which theearpiece is usable; and if the ear at which the at least one earpiece islocated is not the ear at which the earpiece is usable, send a controlsignal from the personal computing device to the ear stimulation deviceto prevent delivery of the stimulus to the a least one nerve innervatingthe ear of the user. In addition to the foregoing, other system aspectsare described in the claims, drawings, and text forming a part of thedisclosure set forth herein.

In an aspect, a method of controlling an ear stimulation device with apersonal computing device includes, but is not limited, to detecting atelectrical signal input circuitry, via at least one first electrode ofan earpiece of an ear stimulation device, an electrical signalindicative of electrical contact of the at least one first electrodewith the ear of a user of a personal computing device, wherein the atleast one earpiece is operably connected to the personal computingdevice, and wherein the ear stimulation device is adapted to stimulateat least one nerve innervating the ear of the user of the personalcomputing device; determining, using contact determination circuitry onthe personal computing device, whether the at least one first electrodeis in good electrical contact with the ear of the user; if the at leastone first electrode is not in good electrical contact with the ear ofthe user, sending a control signal from the personal computing device tothe ear stimulation device, under control of neural stimulus controlsignal determination circuitry on the personal computing device, toprevent delivery via the earpiece of a stimulus to the ear at which theearpiece is located; and delivering, under control of notificationcircuitry on the personal computing device, a notification to the userrelating to the status of the at least one first electrode. In additionto the foregoing, other method aspects are described in the claims,drawings, and text forming a part of the disclosure set forth herein.

In an aspect, an ear stimulation device control system includes, but isnot limited to, a personal computing device configured to controldelivery via an ear stimulation device of a stimulus to at least onenerve innervating an ear of a user of the personal computing device, theear stimulation device including at least one first electrode, and thepersonal computing device including electrical signal circuitry adaptedto receive an electrical signal indicative of electrical contact of theat least one first electrode with the ear of a user of the personalcomputing device; contact determination circuitry configured todetermine whether the at least one first electrode is in good electricalcontact with the ear of the user; neural stimulus control signaldetermination circuitry configured to send a control signal from thepersonal computing device to the ear stimulation device to preventdelivery of the stimulus if the at least one first electrode is not ingood electrical contact with the ear of the user; and notificationcircuitry configured to deliver a notification to the user relating tothe status of the at least one first electrode. In addition to theforegoing, other system aspects are described in the claims, drawings,and text forming a part of the disclosure set forth herein.

In an aspect, a personal computing device application for monitoring useof a nerve stimulation system by a user includes, but is not limited to,an audio delivery module adapted to control delivery of an audio signalfrom an audio signal source to an audio earpiece via an audio output ofthe personal computing device, the audio earpiece having associatedtherewith an ear stimulation device configured to stimulate a nerveinnervating the ear of the user; a mood assessment module adapted toreceive mood-related input from the user via a first input structureassociated with the personal computing device; and assess a mood of theuser based at least in part upon the mood-related input; a secondaryfactor input module adapted to receive at least one input relating to atleast one secondary factor relating to the user via a second inputstructure associated with the personal computing device; user controlmodule adapted to receive at least one user control input via a thirdinput structure of the personal computing device, the user control inputfor controlling user-controllable stimulation parameters of the earstimulation device; a stimulator control module adapted to determine atleast one stimulus control parameter based on at least one of the moodof the user, the at least one secondary factor, and the at least oneuser control input; and a controller interface module for communicatingthe at least one stimulus control parameter to a stimulator controlleradapted to control the ear stimulation device responsive to the at leastone stimulus control parameter. In addition to the foregoing, othersystem aspects are described in the claims, drawings, and text forming apart of the disclosure set forth herein.

In an aspect, a method of controlling an ear stimulation device with apersonal computing device includes, but is not limited to, receiving anaudio signal at the personal computing device from an audio signalsource; delivering the audio signal to an audio earpiece worn by a uservia an audio output of the personal computing device, the audio earpiecehaving associated therewith an ear stimulation device configured tostimulate a nerve innervating the ear of the user; receiving with a moodassessment module, via a first input structure associated with thepersonal computing device, a mood-related input from the user;assessing, with the mood assessment module, a mood of the user based atleast in part upon the mood-related input; receiving with a secondaryfactor input module, via a second input structure associated with thepersonal computing device, at least one input relating to at least onesecondary factor relating to the user; receiving with a user controlmodule, via a third input structure associated with the personalcomputing device, at least one user control input for controlling atleast one user-controllable stimulation parameter of the ear stimulationdevice; determining, with a stimulator control module, at least onestimulus control parameter based on at least one of the mood of theuser, the at least one secondary factor, and the at least one usercontrol input; and communicating, with a controller interface module, atleast one stimulus control parameter to a stimulator controller, thestimulator controller adapted to control the ear stimulation deviceresponsive to the at least one stimulus control parameter. In additionto the foregoing, other method aspects are described in the claims,drawings, and text forming a part of the disclosure set forth herein.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an illustration of the external anatomy of the ear of a human.

FIG. 2A is an illustration of a system including a neural stimulationdevice worn on the ear of a subject.

FIG. 2B is a block diagram of the system of FIG. 2A.

FIG. 3 depicts a stimulation device including a securing memberconfigured to fit in the concha, and a clip securing member.

FIG. 4A depicts a stimulation device including a hanger-style securingmember.

FIG. 4B depicts the stimulation device of FIG. 4A positioned on an ear.

FIG. 5 depicts an embodiment of a stimulation device.

FIG. 6 depicts an embodiment of a stimulation device.

FIG. 7 is a block diagram of a neural stimulation system.

FIG. 8 is a block diagram of a computing system.

FIG. 9 is a flow diagram of a method.

FIG. 10 is a block diagram of a neural stimulation device.

FIG. 11 is a flow diagram of a method.

FIG. 12 is a block diagram of a neural stimulation system.

FIG. 13 is a block diagram of a system including a personal computingdevice.

FIG. 14 is a flow diagram of a method.

FIG. 15 is a block diagram of a computer program product relating to themethod of FIG. 14.

FIG. 16 is a block diagram of a system including a personal computingdevice.

FIG. 17 is a flow diagram of a method.

FIG. 18 is a block diagram of a computer program product relating to themethod of FIG. 17.

FIG. 19 is a block diagram of a system including a personal computingdevice.

FIG. 20 is a flow diagram of a method.

FIG. 21 is a block diagram of a computer program product relating to themethod of FIG. 20.

FIG. 22 is a block diagram of a system including a personal computingdevice.

FIG. 23 is a flow diagram of a method.

FIG. 24 is a block diagram of a computer program product relating to themethod of FIG. 23.

FIG. 25 is a block diagram of a system relating to operation of a neuralstimulation device.

FIG. 26 depicts data aspects relating to FIG. 25.

FIG. 27 is a flow diagram of a method.

FIG. 28 is block diagram of a computer program product relating to themethod of FIG. 27.

FIG. 29 is an illustration of an embodiment of a system for deliveringneural stimulation in combination with a secondary stimulus.

FIG. 30 is a flow diagram of a method.

FIG. 31 is a flow diagram of a method.

FIG. 32 is a flow diagram of a method.

FIG. 33 is a flow diagram of a method.

FIG. 34 is a block diagram of a neural stimulation system.

FIG. 35A depicts a user interface for a neural stimulation system.

FIG. 35B depicts a user interface for a neural stimulation system.

FIG. 36 is a block diagram of an embodiment of a neural stimulationsystem.

FIG. 37 is a flow diagram of a method.

FIG. 38 is a flow diagram of a method.

FIG. 39 is a flow diagram of a method.

FIG. 40 is a block diagram of a system including a personal computingdevice.

FIG. 41 is a flow diagram of a method.

FIG. 42 is a flow diagram of a method.

FIG. 43 is a flow diagram of a method.

FIG. 44 is a flow diagram of a method.

FIG. 45 is a flow diagram of a method.

FIG. 46 is a flow diagram of a method.

FIG. 47 is a flow diagram of a method.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

Various studies indicate that stimulation of the ear can have beneficialeffects on the health of a subject. For example, Rong et al.,“Transcutaneous vagus nerve stimulation for the treatment of depression:a study protocol for a double blinded randomized clinical trial,” BMCComplementary and Alternative Medicine 2012, 12:255, which isincorporated herein by reference, describes the possibility of usingtranscutaneous stimulation of the vagus nerve via portions of the ear totreat major depressive disorder (MDD) and other disorders, includingepilepsy, bipolar disorder, and morbid obesity. Ellrich, “TranscutaneousVagus Nerve Stimulations,” European Neurological Review, 2011;6(4):254-256, which is incorporated herein by reference, describestranscutaneous vagus nerve stimulation via the ear for treating epilepsyand depression.

Nerves innervating the skin on or in the vicinity of the ear of thesubject include, e.g., the facial nerve (cranial nerve VII), theglossopharyngeal nerve (cranial nerve IX), the auricular branch of thevagus nerve (cranial nerve X), the auriculotemporal branch of trigeminalnerve (cranial nerve V), the lesser occipital nerve (spinal nerve C3),and the greater auricular nerve (spinal nerves C2, C3). These nervescontain various nerve fibers including sensory nerve fibers, including,for example, nerve fibers from skin mechanoreceptors. Various types ofskin mechanoreceptors are well characterized and are innervated byfibers having diameters in the range of approximately 5 to 12 μm (alsoknown as Aβ fibers). Skin mechanoreceptors include, for example, slowlyadapting mechanoreceptors, which are more sensitive to continuousstimulation, and rapidly adapting mechanoreceptors, which are moresensitive to transient stimuli. Rapidly adapting mechanoreceptorsinclude Pacinian corpuscles and Meissner's corpuscles, for example.

Mechanoreceptors are activated well by cyclical or vibratory (e.g.,sinusoidal) mechanical stimuli having frequencies in the range of 1 Hzto 1000 Hz. In some aspects, such mechanical stimuli may includeindentation of the skin by a few micrometers to a few millimeters.Pacinian corpuscles are thought to be most responsive to vibratorymechanical stimuli with frequencies in the range of 200 Hz-300 Hz, whileMeissner's Corpuscles are thought to be most responsive to vibratorymechanical stimuli with frequencies in the range of 30-40 Hz.

Electrical stimuli having sinusoidal or other waveforms are alsoeffective for activating sensory fibers. Stimuli may be appliedcyclically, for example. See e.g., Ellrich, “Transcutaneous Vagus NerveStimulations,” European Neurological Review, 2011; 6(4):254-256, whichis incorporated herein by reference.

For reference, FIG. 1 depicts an ear 100 of a human subject, showinganatomical structures which may be referred to herein. The externalportion of ear 100 is referred to as the pinna 102. FIG. 1 depicts afront/side view of ear 100, showing anterior surface of pinna 104, and aback view of ear 100, showing posterior surface of pinna 106 as well ashead 108 of the subject. The surface of the head 108 adjacent the pinna102 is indicated by shading and reference number 110. Anatomicalfeatures of the ear include external auditory meatus 112 (the externalear canal), helix 114, lobe 116, and tragus 118. Concha 120, theindented region in the vicinity of external auditory meatus 112, iscomprised of cymba 122 and cavum 124, and bounded by antitragus 126 andantihelix 128. Antihelix 128 includes inferior (anterior) crus ofantihelix 130 and superior (posterior) crus of antihelix 132, whichbound triangular fossa 134.

FIGS. 2A and 2B depict a generalized system 200 including a wearableneural stimulation device 202 for delivering a stimulus to an ear 204 ofa subject 206. System 200 includes a personal computing device 208 incommunication with wearable neural stimulation device 202 viacommunication link 210. Personal computing device 208 can be an audioplayer, a mobile phone, a computer, or any of various other deviceshaving computing capability (e.g., microprocessor based devices) andincluding application software and/or suitable hardware for controllingoperation of wearable neural stimulation device 202. In an aspect,personal computing device 208 is a wearable computing device. In anaspect, wearable neural stimulation device 202 is used to deliver astimulus sufficient to activate one or more nerves or nerve branchesinnervating the skin on or in the vicinity of ear 204 of subject 206. Inan aspect, personal computing device 208 is used to control delivery ofthe stimulus to ear 204 of subject 206. As illustrated in the blockdiagram of FIG. 2B, and described in greater detail herein below,wearable neural stimulation device 202 includes neural stimulator 212and securing member 214 for securing neural stimulator 212 to ear 204.In an aspect, personal computing device 208 is configured to send, orreceive, information relating to operation of the wearable neuralstimulation device 202 to, or from, one or more remote system 216 via acommunications network 218. Control of stimulation may be based on datafrom one or more sensor 220, including, but not limited to,physiological sensors, neural activity sensors, motion sensors, locationsensors, or environmental sensors, for example. In some aspects, sensor220 is worn by the subject at a location distinct from wearable neuralstimulation system 202 (e.g., on an armband as depicted in FIG. 2A). Inother aspects, one or more sensors are located on a wearable neuralstimulation device that can be implanted in the subject, located on thepersonal computing device, or located elsewhere in the environment ofthe subject, as depicted and described in the following text andaccompanying figures.

In the embodiment of FIGS. 2A and 2B, and in other embodiments describedherein, neural stimulator 212 can be any of various types of neuralstimulators, including but not limited to mechanical, electrical,magnetic, ultrasonic, optical, or chemical stimulators, as will bediscussed in greater detail herein below. In an aspect, neuralstimulation devices as described herein can include multiple (two ormore) neural stimulators (see e.g., optional additional neuralstimulator 222 in FIG. 2B). If multiple neural stimulators are used,they may all be of the same type, or may be of several different types.

In an aspect, neural stimulator 212 is a mechanical stimulator. In anaspect, a mechanical stimulator includes, for example, a vibratorymechanical stimulator that delivers a cyclical or vibrating mechanicalstimulus to the skin of the ear of the subject. Vibratory mechanicalstimulators can include, for example, various types of vibratingmechanical devices, e.g., electromechanical, piezoelectric, movablecoil, electrostatic, magnetostrictive, isodynamic, and/or MEMS devices,for example as used for manufacturing small-scale speakers andmicrophones.

In an aspect, neural stimulator 212 includes a transcutaneous electricalstimulator for delivering a transcutaneous electrical stimulus. Forexample, neural stimulator 212 may include an electrode or electricalcontact designed for contacting the skin surface, for example asdescribed in Rong et al., “Transcutaneous vagus nerve stimulation forthe treatment of depression: a study protocol for a double blindedrandomized clinical trial,” BMC Complementary and Alternative Medicine2012, 12:255, which is incorporated herein by reference. In an aspect,neural stimulator 212 includes a magnetic stimulator for delivering atranscutaneous magnetic stimulus. For example, such a magneticstimulator may include one or more coil through which electrical currentis passed to generate a magnetic field. The magnetic field induceselectrical currents within the tissue in/around the ear of the subjectto activate neural structures. In an aspect, neural stimulator 212includes an ultrasonic stimulator, for example as described in Legon etal., “Pulsed Ultrasound Differentially Stimulates Somatosensory Circuitsin Humans as Indicated by EEG and fMRI,” PLOS ONE 7(12): e5177.Doi:10.01371/journal.pone.0051177, December 2012, which is incorporatedherein by reference. In some aspects, other types of neural stimulators,such as optical or chemical stimulators are used. See, for example,stimulators described in U.S. Pat. No. 8,170,658 to Dacey, Jr. et al.,which is incorporated herein by reference.

In some aspects, circuitry for driving delivery of the neural stimulusis included fully or partially in wearable neural stimulation device202. In some aspects, some or all of the circuitry for driving deliveryof the neural stimulus are housed separately from wearable neuralstimulation device 202, and a control signal for driving delivery of theneural stimulus by neural stimulator 212 is provided by personalcomputing device 208, or from remote system 216 via communicationnetwork 218.

Various examples and embodiments of neural stimulation devices aredescribed herein. In various aspects of neural stimulation systemsdescribed herein, neural stimulation devices are wearable, i.e. thedevice can be carried by or worn on the ear of a subject, secured by asecuring member, in order to position one or more neural stimulator withrespect to a portion of the ear of the subject, or in some cases, in thevicinity of the ear of the subject. Various types of securing membersmay be used, without limitation. A securing member may also serve toposition one or more sensors on or in the vicinity of the ear of thesubject and may also include or support other system components, such aselectrical circuitry components. Examples of neural stimulation devicesincluding different types of securing members are shown in FIGS. 3-6.

FIG. 3 depicts securing member 300, which is a concha-fitted memberconfigured to fit into concha 302 of ear 304. In this example, securingmember 300 has a size and shape sufficient to be retained in concha 302by friction and/or tensioning of securing member 300 with respect toconcha 302. Other system components may be attached to securing member300, e.g., ear canal insert 306, which extends into external auditorymeatus (ear canal) 308 and stimulators 310 a, 310 b, and 310 c. Inaddition, system components may be built into or contained withinsecuring member 300, e.g., control and/or communication circuitry (notshown) used to drive stimulators 310 a, 310 b, and 310 c and/or providefor communication with e.g., a personal computing device (not shown). Abattery can be provided in securing member 300 to power the device forwireless operation. FIG. 3 also depicts a second type of securingmember, clip 312, for attaching stimulator 314 and/or sensor 316 to thepinna 318 of the subject. Circuitry 320 provides for wirelesscommunication between stimulator 314/sensor 316 and circuitry onsecuring member 300 or a personal computing device or remote system.Spring 322 provides spring force to secure clip 312 onto pinna 318. Clip312 may be formed of a resilient material or formed from two sections ofrigid material, joined at a hinge.

FIGS. 4A and 4B depict securing member 400 having a hanger-styleconfiguration designed to hang on pinna 402. The hanger-styleconfiguration is similar to the configuration used in certain types ofheadsets for listening to music. Securing member 400 includes anteriorportion 404, which in use (shown in FIG. 4B) is positioned anterior tothe ear of the subject (i.e. in front of pinna 402); over-ear portion406, which arcs over and behind pinna 402; and posterior portion 408,which fits behind pinna 402. In an aspect, securing member 400 includesdownward extension 410. In an aspect, wired communication link 412(e.g., a cable) provides for connection of electrical components onsecuring member 400 to a remote computing device. For example,electrodes 414 a and 414 b on posterior portion 408 of securing member400 are used to deliver electrical stimulation under control of acontrol signal delivered via wired communication link 412. Securingmember 400 also includes ear canal insert 416, which fits into theexternal auditory meatus 112. A sensor 418 on ear canal insert 416 canbe used to sense a physiological signal, which in some aspects is usedto determine the stimulation delivered with electrodes 414 a and 414 b.Physiological sensor 418 may include, for example, an electrode forsensing a heart rate, or other physiological sensor as described ingreater detail elsewhere herein. Additional sensors 420 and 422 arelocated on the aspect of posterior portion 408, facing and adapted tocontact the surface of the head adjacent the pinna 402. In an aspect,sensors 420 and 422 are electrodes configured to detect anelectroencephalographic (EEG) signal.

FIG. 5 depicts securing member 500 having a loop configuration of a typeused for wireless headsets. Securing member 500 includes earpieces 502 aand 502 b, which fit into the left and right ears of a subject,respectively (e.g., fitting into one or both of the concha and externalauditory meatus). Securing member 500 also includes arcs 504 a and 504b, which fit over and behind the two ears of the subject, and connectingloop 506 which fits behind the head of the subject and connectsearpieces 502 a and 502 b. In an aspect, securing member 500 issufficiently rigid to maintain earpieces 502 a and 502 b in position inthe ears of the subject while the subject moves about (e.g., walking orrunning). In an aspect, ear canal inserts 508 a and 508 b fit into theear canals of the subject. A neural stimulator 510 may be positioned onearpiece 502 a, as shown, or alternatively (or in addition) on ear canalextension 508 a. A secondary neural stimulator 512 may be located onpinna extension 514. Extension 514 serves to position secondary neuralstimulator 512 on the pinna of the subject at a desired location. In anaspect, extension 514 can be adjusted by elastic or plastic deformationto change the positioning of neural stimulator 512 on the pinna. In someaspects, extension 514 can include an adjustable linkage that providesfor positioning of neural stimulator 512 with respect to the pinna.

FIG. 5 depicts a system in which neural stimulators 510 and 512 arepositioned on securing member 500 so as to deliver stimulation to theleft ear of the subject. Depending upon the desired application, neuralstimulators can be positioned on one or both ears of the subject. Insome aspects, stimulation is delivered to only one ear, while in otheraspects, stimulation is delivered to both ears.

In some aspects, stimulator 512 located on pinna extension 514 can beused as the only, or primary neural stimulator, and stimulator 510 onearpiece 502 a can be omitted. Earpieces 502 a and 502 b can function tohold securing member 500 in place with respect to the head of thesubject, and, optionally, to deliver sound (such as a voice signal froma phone or music from an audio player) to the ears of the subject,independent of carrying stimulator 510. Circuitry 516 in securing member506 includes communication circuitry for wirelessly communicating withother system components, for example a personal computing device (e.g.,an audio player, a mobile phone, or a laptop computer). In addition,circuitry 516 may provide for wireless communication with a sensorlocated at a distance from securing member 500. For example, thewireless headset device depicted in FIG. 5 can be used in combinationwith sensors in one or more locations, not limited to sensors onsecuring member 500. Sensors include any type of physiological sensorlocated in, on or adjacent to the body of the subject (e.g., implantedsensors, sensors secured to the body, sensors in wearable items such asclothing, wristbands); remote sensors, environmental sensors, motionsensors, location sensors, and/or other types of sensors, withoutlimitation.

FIG. 6 depicts a further example of a wearable neural stimulation device600 including a housing 602 attached to a securing member 604. Housing602 is shown only in a dashed outline so that the position of stimulator606 and sensor 608 with respect to ear 610 can be seen. Housing 602 is athin, flat box-like structure, with stimulator 606 and sensor 608mounted on the exterior of housing 602 on the side facing pinna 612.Housing 602 is fastened to or formed integrally with securing member604. Securing member 604 fits into concha 614 to secure device 600 toear 610. Ear canal insert 616 fits into external auditory meatus 618.Sensor 620 on ear canal insert 616 senses a physiological signal fromexternal auditory meatus 618. Sensor 608 is an environmental sensor thatsenses light from the environment of the subject, e.g., to determinewhether it is day or night.

FIG. 7 is a block diagram of a neural stimulation system 700. Neuralstimulation 700 system includes neural signal sensor 702, which isadapted to sense a neural signal 704 from a subject. Neural signal 704may be an electroencephalographic (EEG) signal or electrooculographic(EOG) signal, and in an aspect is indicative of a physiological statusof the subject. Neural stimulation system 700 also includes neuralstimulator 706, which is adapted to produce a stimulus 708 responsive tosensed neural signal 704, stimulus 708 configured to activate at leastone sensory nerve fiber innervating at least a portion of a pinna of thesubject. Neural stimulation system 700 also includes securing member 710configured to secure neural stimulator 706 to the pinna of the subject.

In various aspects, neural signal sensor 702 can be anelectroencephalographic signal sensor 712 or electrooculographic signalsensor 714. Electroencephalographic signal sensor 712 can be configuredto fit within an ear canal of a subject, e.g., on an ear canal insert asdepicted in FIG. 4A (for example as described in U.S. Patent Publication2003/0195588 to Fischell et al., or U.S. Patent Publication 2006/0094974to Cain, both of which are incorporated herein by reference). EOG sensor714 can be located on an extension (e.g., similar to extension 514 shownin FIG. 5) to position EOG sensor 714 on the subject's temple or side ofthe subject's head. An electromyographic signal sensor could besimilarly placed. Physiological status of the subject, as indicated byneural signal 704, may include indications or symptoms of various typesof physiological status, including various brain-related disorders orstatuses, or other physiological statuses. Brain-related disordersinclude, for example, mental health disorders (e.g., psychological orpsychiatric disorder), depression, post-traumatic stress disorder,seasonal affective disorder, anxiety, headache (e.g., primary headache,cluster headache, or migraine headache), or epilepsy). Neural signalsensor 704 may include other types of neural signal sensors, includingexternal or implantable sensors, located in or on the ear or other partof the body. One or more neural signal sensors may be used.

In various aspects, securing member 710 is configured to secure neuralstimulator 706 to different portions of the pinna of the subject. Forexample, in an aspect, securing member 710 includes a concha-fittedportion 716, configured to fit into the concha of the subject (e.g., asdepicted in FIG. 3). In an aspect, securing member 710 includes an earcanal insert 718 configured to fit in the ear canal of the subject(e.g., as depicted in FIGS. 4A, 4B, and 5). In another aspect, securingmember 710 is a hanger-style securing member 720, as depicted in FIGS.4A and 4B. Hanger-style securing member 720 can be used to secure theneural stimulator to the back of the pinna, or to the surface of thehead adjacent the pinna. In another aspect, securing member 710 is aloop-style securing member 722, (e.g., of the type depicted in FIG. 5).In another aspect, securing member 710 includes a clip 724 (e.g., of thetype depicted in FIG. 3). A clip may be used to secure neural stimulator706 to various parts of the front or back of the pinna, including thefront or back of the ear lobe. In another aspect, securing member 720includes an extension 726 (e.g., such as extension 514 depicted in FIG.5). Such an extension can be used to position the neural stimulator invirtually any desired position on the pinna, or on the head adjacent toand above, below, in front of, or behind the ear. In an aspect, securingmember 710 includes a housing 728. It should be noted that housing 710may in some cases function as an extension. For example, housing 602depicted in FIG. 6 also functions as an extension extending fromsecuring member 604 to provide for placement and securing of stimulator606 and sensor 608 on a portion of the pinna 612 not immediatelyadjacent securing member 604. Securing member 710 can be configured tosecure the neural stimulator to the concha, tragus, front or back of thepinna, the helix, or various other parts of the pinna, e.g., thetriangular fossa, antihelix, superior or inferior crus of the antihelix,antitragus, or tragus of the subject. In some aspects securing member710 is permanently configured to position neural stimulator 706 in aparticular position with respect to the ear of the subject, wherein insome aspects securing member 710 is adjustable such that the positioningof neural stimulator 706 can be selected by the subject. For example, asensor or stimulator may be secured to a particular portion of the pinnaby being pressed sufficiently firmly against the pinna by the securingmember or extension to form a reliable mechanical or electrical contactwith the pinna. In an aspect, securing member 710 includes a shapememory material. Various materials may be suitable for the constructionof securing member 710, including but not limited to hard or soft,elastically or plastically deformable polymers, metals, ceramics,glasses, and composites formed therefrom. Flexible or stretchableelectronic circuitry, formed from flexible materials or structures (e.g.conductors having, e.g., a serpentine design) or resilient conductivematerials such as conductive polymers can be used in sensors andstimulators that conform to the pinna. While discussion herein hasfocused on positioning of the neural stimulator by securing member 710,it will be appreciated that securing member 710 can also be configuredto position sensors with respect to the ear in a similar fashion.Several such examples are provided in FIGS. 3-6.

In an aspect, the neural stimulator 706 is positioned with respect tosecuring member 710 such that when securing member 710 is worn on thepinna, neural stimulator 706 is positioned (secured) over a specificregion of the pinna, e.g., a region of the pinna innervated by a cranialnerve, e.g., the vagus nerve, the facial nerve, the trigeminal nerve, orthe glossopharyngeal nerve. Such positioning may be selected based uponknowledge of the innervation of the pinna, for example, as provided inreferences texts such as Cranial Nerves in Health and Disease, by LindaWilson-Pauwels, Elizabeth J. Akesson, Patricia A. Stewart, and Sian D.Spacey; BC Decker Inc.; 2 edition (Jan. 1, 2002); ISBN-10:1550091646/ISBN-13: 978-1550091649, which is incorporated herein byreference.

As noted above, neural stimulator 706 may be, for example, a mechanicalstimulator 730 (e.g., a vibratory mechanical stimulator 732), atranscutaneous electrical stimulator 734, a transcutaneous magneticstimulator 736, an ultrasonic stimulator 738, a chemical stimulator 740,a thermal stimulator 742, or other type of stimulator.

As shown in FIG. 7, in an aspect, neural stimulation system 700 includesat least one secondary sensor 750. In an aspect, neural signal sensor702 is a primary neural signal sensor, and secondary sensor 750 is asecondary neural signal sensor 752, which may be, for example, anelectroencephalographic (EEG) sensor 754, or electrooculographic (EOG)sensor 756. The secondary neural signal sensor 752 may be of the same ordifferent type as primary neural signal sensor 702, and may be locatedat the same or different location on the body as primary neural signalsensor 702. In an aspect, secondary sensor 750 is a physiological sensor758, for example, an electromyographic (EMG) sensor 755, a heart ratesensor 760 (which may be used to heart rhythm variability, as well asheart rate, and may include, but is not limited to, and EKG orpulse-oximeter based heart rate sensor), blood pressure sensor 762,perspiration sensor 764, skin conductivity sensor 766, respirationsensor 768, pupil dilation sensor 770, digestive tract activity sensor772, or piloerection sensor 774. In another aspect, secondary sensor 750is an environmental sensor, for example a light sensor 782, which may beconfigured to sense light level 784 and or day length 786. Environmentalsensor 750 may include a temperature sensor 788, or an acoustic sensor790, e.g., configured to sense ambient noise level 792. Other types ofsensors for providing information regarding the state of the subject andhis or her environment may be used, without limitation, including motionsensor 794 or location sensor 796, for example. A variety ofphysiological and environmental sensors are described in U.S. Pat. No.8,204,786 to LeBoueuf et al., which is incorporated herein by reference.Digestive tract activity may be sensed with external acoustical sensors,for example as described in “New disposable biosensor may helpphysicians determine which patients can safely be fed followingsurgery,” MedicalXpress, Aug. 7, 2014, which is incorporated herein byreference.

In an aspect, neural stimulation system 700 includes a secondary signalinput 800. In various aspects, the signal received at secondary signalinput 800 includes a signal from a delivery device 802 (indicative ofdelivery of a drug or nutraceutical to the subject), an input to a game804 (e.g., a signal corresponding to the subjects input to a video gameplayed by the subject), an output from a game 806 (e.g., a signal outputby a game system indicative of a state of or an event in a game playedby the subject), a user input to a virtual reality system 808, an outputfrom a virtual reality system 810 (e.g., a signal output by the VRsystem indicative of an state of or an event in the VR system), a userinput device 812 (e.g., a user input device of a computing device or auser input to the neural stimulation system), or a computing deviceinput 814 (e.g., a data input). Inputs received via a user input deviceor computing device input may be indicative of intake of a food item,beverage, nutraceutical, or pharmaceutical by the subject, for example.Inputs received via a user input device may be provided by the subject,or by another user, e.g. a medical caregiver. Inputs may be providedspontaneously by the user, or in response to a prompt or query. In anaspect, inputs may be provided by the user in response to queries orprompts that form a part of a quiz, questionnaire, or survey, including,e.g. questions presented in yes/no or multiple choice response format.User responses provided in response to such prompts or queries mayindicate the subject's mental or emotional state. Inputs received via adata input may include, for example, health-related information of thesubject, including genome information or microbiome information of thesubject, information from medical-records of the subject, or otherinformation pertaining to the health of the subject.

In an aspect, neural stimulation system 700 includes a clock or timer816. In various aspects, neural stimulator 706 is adapted to producestimulus 708 based at least in part on a time of day indicated byclock/timer 816, and/or based at least in part on a date indicated byclock/timer 816.

Data drawn from one or more neural signals, physiological signals,environmental signals, or other secondary signals (e.g. obtained withsecondary sensor 750 in FIG. 7) or secondary inputs (e.g. secondarysignal input 800 in FIG. 7), as well as clock or timer information, canbe correlated with a mental or emotional state of the subject, reportedto a medical care provider or other party, and/or stored in thesubject's medical or health records. In particular, values of any suchparameters that are indicative of worsening mental orphysical/physiological status of the subject can be reported to amedical care provider so that an appropriate intervention can be made,and/or used as a basis for modulating the delivery of neuralstimulation.

In various aspects, neural stimulation system 700 includes at least onesecondary stimulator 818 for delivery a secondary stimulus 820 to thesubject. In an aspect, secondary stimulator 818 is a secondary neuralstimulator 822, which may be any of the various types of neuralstimulators described in connection with neural stimulator 706, andwhich may be of the same or different type as neural stimulator 706.Alternatively, secondary stimulator 818 may include a mechanicalstimulator 824, an audio player 826, an auditory stimulus source 828, avirtual reality system 830, an augmented reality system 832, a visualstimulus source 834, a tactile stimulator 836, a haptic stimulator 838,an odorant source 840, a virtual therapist, or a delivery device 844,for delivering a drug or nutraceutical, for example.

In various aspects, neural stimulation system 700 includes controlcircuitry 846 carried by securing member 710 (either directly onsecuring member 710, or on an extension or housing connected to securingmember 710, e.g., as depicted in FIGS. 3-6), the control circuitry 846configured to control neural stimulator 706.

In an aspect, neural stimulation system 700 includes communicationcircuitry 848 carried by securing member 710 and configured for at leastone of sending one or more signal 850 to a personal computing device 852and receiving one or more signal 854 from personal computing device 852.

In an aspect, neural stimulation system 700 includes a sound source 856,for delivering an auditory signal to the subject. Sound source 856 maybe, for example, a speaker 858. Sound source 856 may be configured(e.g., with appropriate electronic circuitry, not shown) to delivery aninstruction 860 or alert 862 to the subject.

In an aspect, neural stimulation system 700 includes position sensor 864for sensing the position of neural stimulator 706 with respect to thepinna of the subject. Position sensor 864 may detect the position ofneural stimulator 706 with respect to the pinna by detecting electricalactivity from a nerve, by detecting an image of the ear and determiningthe position based on landmarks in the image, or by detecting atemperature, pressure, or capacitive signal indicative of adequatecontact of the stimulator with the ear, for example.

In an aspect, neural stimulation system 700 includes connector 866 forconnecting the neural stimulator to a personal computing device.Connector 866 includes, for example, a jack or port for creating a wired(cable) connection with the personal computing device. In an aspect,neural stimulation system 700 includes user interface 867 for receivinginput from the subject or presenting information to the subject. In anaspect, user interface 867 includes a small display, one or moreindicator lights and simple user inputs, such as one or more buttons ordials for adjusting device setting and viewing and modifying systemsettings.

FIG. 8 illustrates a generalized form of circuitry-based systems asdepicted in FIG. 7 and elsewhere herein. Although specific embodimentsare described herein, those skilled in the art will appreciate thatmethods and systems as described herein can be implemented in variousways. Reference is made herein to various circuitry systems andsubsystems (e.g., neural stimulation system 700 includescontrol/processing circuitry 846 in FIG. 7, which may be considered tobe control/processing circuitry. As shown generically in FIG. 8, asystem 870 includes a circuitry-based system 872. Circuitry-based system872, which in some aspects is a computing device or computing subsystem,includes control/processing circuitry 874, which includes any or all ofdigital and/or analog components 876, one or more processor 878 (e.g., amicroprocessor), and memory 880, which may store one or more programmodule 882 and/or data 884. In some aspects, control/processingcircuitry provides for preliminary handling of data from one or moresensor 886, transfer of data to remote device 896, receipt of controlsignal from remote device 896, and actuation of actuator 888, which maybe for example a neural stimulator (such as neural stimulator 706 asshown in FIG. 7). Systems as described herein may receive signals fromvarious sensors (e.g., sensor 886 depicted in FIG. 8). System 870 mayinclude other components as known to those skilled in the art, e.g., oneor more power supply 890, I/O structure 892, clock, timer, data bus,etc. I/O structure 892 permits communication with various types of userinterface devices (represented by user interface 894, which may includeone or more input devices such as a keyboard, button, switch, computermouse, or touchscreen or one or more output devices such as screen,sound source, alphanumeric display, Braille display, etc.) andcommunication with various types of remote device 896, e.g., remotesystem 216 in FIGS. 2A-2B, which may have control/processing capabilityconferred by control/processing circuitry 898.

In a general sense, the various embodiments described herein can beimplemented, individually and/or collectively, by various types ofelectrical circuitry having a wide range of electrical components suchas hardware, software, firmware, and/or virtually any combinationthereof. Electrical circuitry (including control/processing circuitry846 in FIG. 7, for example) includes electrical circuitry having atleast one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming acomputing device configured by a computer program (e.g., a computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device, which may include various types of memory (e.g., randomaccess, flash, read only, etc.)), electrical circuitry forming acommunications device (e.g., communication circuitry 848 in FIG. 7)(e.g., a modem, communications switch, optical-electrical equipment,etc.), and/or any non-electrical analog thereto, such as optical orother analogs (e.g., graphene based circuitry). In an embodiment, thesystem is integrated in such a manner that the system operates as aunique system configured specifically for function of the neuralstimulation system described herein. In an embodiment, one or moreassociated computing devices of the system operate as specific usecomputers for purposes of the claimed system, and not general usecomputers. In an embodiment, one or more of the associated computingdevices of the system are hardwired with a specific ROM to instruct theone or more computing devices.

In a general sense, the various aspects described herein which can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, and/or any combination thereof can beviewed as being composed of various types of “electrical circuitry.”

At least a portion of the devices and/or processes described herein canbe integrated into a data processing system. A data processing systemgenerally includes one or more of a system unit housing, a videodisplay, memory such as volatile or non-volatile memory, processors suchas microprocessors or digital signal processors, computational entitiessuch as operating systems, drivers, graphical user interfaces, andapplications programs, one or more interaction devices (e.g., a touchpad, a touch screen, an antenna, etc.), and/or control systems includingfeedback loops and control motors (e.g., feedback for sensing positionand/or velocity; control motors for moving and/or adjusting componentsand/or quantities). A data processing system may be implementedutilizing suitable commercially available components, such as thosetypically found in data computing/communication and/or networkcomputing/communication systems.

In various embodiments, methods as described herein may be performedaccording to instructions implementable in hardware, software, and/orfirmware. Such instructions may be stored in non-transitorymachine-readable data storage media, for example. The state of the arthas progressed to the point where there is little distinction leftbetween hardware, software, and/or firmware implementations of aspectsof systems; the use of hardware, software, and/or firmware is generally(but not always, in that in certain contexts the choice between hardwareand software can become significant) a design choice representing costvs. efficiency tradeoffs. There are various vehicles by which processesand/or systems and/or other technologies described herein can beeffected (e.g., hardware, software, and/or firmware), and that thepreferred vehicle will vary with the context in which the processesand/or systems and/or other technologies are deployed. For example, ifan implementer determines that speed and accuracy are paramount, theimplementer may opt for a mainly hardware and/or firmware vehicle;alternatively, if flexibility is paramount, the implementer may opt fora mainly software implementation; or, yet again alternatively, theimplementer may opt for some combination of hardware, software, and/orfirmware in one or more machines, compositions of matter, and articlesof manufacture. Hence, there are several possible vehicles by which theprocesses and/or devices and/or other technologies described herein maybe effected, none of which is inherently superior to the other in thatany vehicle to be utilized is a choice dependent upon the context inwhich the vehicle will be deployed and the specific concerns (e.g.,speed, flexibility, or predictability) of the implementer, any of whichmay vary. Optical aspects of implementations will typically employoptically-oriented hardware, software, and or firmware.

In some implementations described herein, logic and similarimplementations may include software or other control structures.Electrical circuitry, for example, may have one or more paths ofelectrical current constructed and arranged to implement variousfunctions as described herein. In some implementations, one or moremedia may be configured to bear a device-detectable implementation whensuch media hold or transmit device detectable instructions operable toperform as described herein. In some variants, for example,implementations may include an update or modification of existingsoftware or firmware, or of gate arrays or programmable hardware, suchas by performing a reception of or a transmission of one or moreinstructions in relation to one or more operations described herein.Alternatively or additionally, in some variants, an implementation mayinclude special-purpose hardware, software, firmware components, and/orgeneral-purpose components executing or otherwise invokingspecial-purpose components.

Implementations may include executing a special-purpose instructionsequence or invoking circuitry for enabling, triggering, coordinating,requesting, or otherwise causing one or more occurrences of virtuallyany functional operations described herein. In some variants,operational or other logical descriptions herein may be expressed assource code and compiled or otherwise invoked as an executableinstruction sequence. In some contexts, for example, implementations maybe provided, in whole or in part, by source code, such as C++, or othercode sequences. In other implementations, source or other codeimplementation, using commercially available and/or techniques in theart, may be compiled//implemented/translated/converted into a high-leveldescriptor language (e.g., initially implementing described technologiesin C or C++ programming language and thereafter converting theprogramming language implementation into a logic-synthesizable languageimplementation, a hardware description language implementation, ahardware design simulation implementation, and/or other such similarmode(s) of expression). For example, some or all of a logical expression(e.g., computer programming language implementation) may be manifestedas a Verilog-type hardware description (e.g., via Hardware DescriptionLanguage (HDL) and/or Very High Speed Integrated Circuit HardwareDescriptor Language (VHDL)) or other circuitry model which may then beused to create a physical implementation having hardware (e.g., anApplication Specific Integrated Circuit).

This detailed description sets forth various embodiments of devicesand/or processes via the use of block diagrams, flowcharts, and/orexamples. Insofar as such block diagrams, flowcharts, and/or examplescontain one or more functions and/or operations, each function and/oroperation within such block diagrams, flowcharts, or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof. Inan embodiment, several portions of the subject matter described hereinmay be implemented via Application Specific Integrated Circuits (ASICs),Field Programmable Gate Arrays (FPGAs), digital signal processors(DSPs), or other integrated formats. However, some aspects of theembodiments disclosed herein, in whole or in part, can be equivalentlyimplemented in integrated circuits, as one or more computer programsrunning on one or more computers (e.g., as one or more programs runningon one or more computer systems), as one or more programs running on oneor more processors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, the mechanisms ofthe subject matter described herein are capable of being distributed asa program product in a variety of forms, and that an illustrativeembodiment of the subject matter described herein applies regardless ofthe particular type of signal bearing medium used to actually carry outthe distribution. Examples of a signal bearing medium include, but arenot limited to non-transitory machine-readable data storage media suchas a recordable type medium such as a floppy disk, a hard disk drive, aCompact Disc (CD), a Digital Video Disk (DVD), a digital tape, acomputer memory, etc. A signal bearing medium may also includetransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link (e.g., transmitter,receiver, transmission logic, reception logic, etc.) and so forth).

FIG. 9 is a flow diagram of a method 900 relating to use of a neuralstimulation system as depicted in FIG. 7. Here and elsewhere, methodsteps outlined with dashed lines represent steps that are included insome, but not all method aspects, and combinations of steps other thanthose specifically depicted in the figures are possible as would beknown by those having ordinary skill in the relevant art. Method 900includes sensing with a neural signal sensor a neural signal indicativeof a physiological status of a subject, the neural signal sensor locatedin or on a portion of a body of the subject, as indicated at 902;determining with signal analysis circuitry at least one parameter of thesensed neural signal, as indicated at 904; and delivering a neuralstimulus with a neural stimulation device worn on a pinna of the subjectresponsive to the sensed neural signal, wherein the neural stimulus isconfigured to modulate the activity of at least one sensory nerve fiberinnervating at least a portion of the pinna of the subject, as indicatedat 906. In an aspect, the neural stimulus is of sufficient frequency andamplitude to modulate the activity of the at least one sensory nervefiber innervating the at least a portion of the pinna of the subject.For example, in various aspects the neural stimulus has a frequency inthe approximate range of 1 Hz-1000 Hz, 10 Hz-500 Hz, 30 Hz-40 Hz, 10Hz-50 Hz, 10 Hz-80 Hz, 50 Hz-100 Hz, or 200-300 Hz. In an aspect, thestimulus has a sinusoidal waveform. In other aspects, the stimulus mayhave a triangular, rectangular, square, trapezoidal, or other waveform,delivered cyclically, with cycle frequencies in the ranges listed above.It will be appreciated that depending on the stimulus waveform or pulseshape, or envelope shape, a given stimulus may include higher or lowerfrequencies. The neural stimulus may be delivered according toprogrammed pattern, which may be stored in memory on the neuralstimulation device or on a personal computing device or other remotedevice in communication with the neural stimulation device. In variousaspects, the neural stimulus is delivered continuously, intermittently,and/or in a time-varying fashion. The neural stimulus may be a pulsedstimulus.

In an aspect, the neural stimulus is delivered with a neural stimulationdevice and/or neural stimulus configured to activate a cranial nerve,such as the vagus nerve, facial nerve, trigeminal nerve, orglossopharyngeal nerve. The neural stimulation device can be configuredto stimulate a particular nerve by one or both of positioning the neuralstimulator on at least a portion of a receptive field of the nerve ofinterest, and selecting the amplitude and other stimulus parameters(e.g. frequency, waveform, duration) of the stimulus delivered toactivate the nerve fibers in the nerve of interest.

In an aspect, the method includes delivering the neural stimulusresponsive to the at least one parameter of the sensed neural signal.The at least one parameter may include, for example, a frequency contentof an electroencephalographic signal, an amplitude of anelectroencephalographic signal, a rate of eye movement determined froman electrooculogram, or a gaze direction determined from anelectrooculogram. In some aspects, such parameters are indicative of abrain-related disorder, or symptoms thereof. In an aspect, method 900includes delivering the neural stimulus in response to detection ofsymptoms of a brain-related disorder (which may be, for example, anymental health disorder (e.g., psychological or psychiatric disorder),depression, post-traumatic stress disorder, seasonal affective disorder,anxiety, headache (e.g., primary headache, cluster headache, or migraineheadache), or epilepsy). In an aspect, the method includes deliveringthe neural stimulus until symptoms of the brain-related disorder are nolonger detected.

In an aspect, method 900 includes sensing at least one secondary signalwith a secondary sensor. In an aspect, delivery of the neural stimulusmay be started, stopped, or modulated in response to the secondarysignal. The secondary signal may be a secondary neural signal (of thesame or different type and sensed from the same or from a differentlocation than the primary neural signal), or it may another type ofphysiological signal, an environmental signal, a location signal, or asignal from a motion sensor, for example. Such secondary signals mayprovide additional information relevant for determining whether theneural stimulus should be applied, assessing the subject's response tothe neural stimulus, identifying appropriate time of delivery of theneural stimulus, etc. The secondary signal may include other types ofsecondary signal, e.g., as received by secondary signal input 800 inFIG. 7. In an aspect, method 900 includes delivering at least onesecondary stimulus to the subject in addition to the neural stimulusdelivered with the neural stimulation device. The secondary stimulus maybe any of various types of secondary stimulus, e.g., as delivered withsecondary stimulator 818 as described in FIG. 7. In various aspects,method 900 includes controlling the neural stimulation device withcontrol circuitry located at least in part on the neural stimulationdevice, or with control circuitry located at least in part on a personalcomputing device in communication with the neural stimulation deviceworn on the pinna of the subject. In an aspect, method 900 includessending a signal from the neural stimulation device worn on the pinna ofthe subject to a personal computing device or receiving a signal from apersonal computing device at the neural stimulation device worn on thepinna of the subject. In an aspect, method 900 includes delivering anauditory instruction or an auditory alert to the subject with a soundsource operatively connected to the neural stimulation device. In anaspect, method 900 includes sensing a position of the neural stimulationdevice relative to the pinna of subject with a position sensoroperatively connected to the neural stimulation device. If the neuralstimulation device is not positioned properly positioned, the auditoryinstruction or alert may remind the subject to correct the positioningof the neural stimulation device. Alternatively, or in addition, visualalerts can be provided to the subject, in the form of one or moreblinking light, graphic, or a text message, delivered via an LED orother light emitting element, an alphanumeric display, a screen, orother display element on the neural stimulation device or on thepersonal computing device.

FIG. 10 depicts an embodiment of a wearable neural stimulation device1000 that includes a vibratory mechanical stimulator 1002. Vibratorymechanical stimulator 1002 is adapted to produce a vibratory stimulus ofsufficient frequency and amplitude to modulate the activity of at leastone mechanoreceptor with a receptive field on at least a portion of apinna of a subject, and a securing member 710 configured to securevibratory mechanical stimulator 1000 to the pinna. Securing member 710is as described herein above. Vibratory mechanical stimulator 1002 is avibratory stimulator, such as vibratory stimulator 732 describedgenerally in connection with FIG. 7. In various aspects, vibratorymechanical stimulator 1002 includes an electromechanical device 1004,piezoelectric device 1006, movable coil 1008, electrostatic device 1010,magnetostrictive device 1012, isodynamic device 1014, a MEMS device1016, and/or a stretchable electronic device 1018.

In an aspect, neural stimulation device 1000 includes at least onesensor 1020, which may be any of the various types of sensors describedin connection with secondary sensor 750 in FIG. 7, e.g., a physiologicalsensor 758, a neural signal sensor 752, an environmental sensor 780, amotion sensor 794 or a location sensor 796. In various aspects, neuralstimulation device 1000 includes a secondary signal input 800, secondarystimulator 818, control circuitry 846 carried by securing member 710,communication circuitry 848, sound source 856, position sensor 864, andconnector 866, all of which have been discussed in connection with FIG.7.

FIG. 11 is a flow diagram of a method 1100 relating to use of a neuralstimulation system as depicted in FIG. 10. In an aspect, method 1100includes delivering a vibratory mechanical stimulus to at least aportion of a pinna of a subject with a neural stimulation device worn onthe pinna of the subject, wherein the vibratory mechanical stimulus isof sufficient frequency and amplitude to modulate the activity of atleast one mechanoreceptor with a receptive field on the at least aportion of the pinna, as indicated at 1102. In an aspect, method 1100includes delivering the vibratory mechanical stimulus over a spatialextent of the pinna sufficient to modulate the activity of the at leastone mechanoreceptor, as indicated at 1104.

In an aspect, the vibratory mechanical stimulus has a waveformsufficient to modulate the activity of the at least one mechanoreceptorwith a receptive field on the at least a portion of the pinna. Forexample, the vibratory mechanical stimulus may have a sinusoidal orother waveform. In some aspects, the vibratory mechanical stimulus isdelivered according to programmed pattern, which may include deliveringthe vibratory mechanical stimulus either continuously or intermittently.

In an aspect, as indicated at 1106, method 1100 includes sensing asignal with a sensor and controlling the delivery of the vibratorymechanical stimulus based at least in part on the sensed signal. Thesensed signal may be any of the various types of signal sensed withsensor 1018 in FIG. 10. In various aspects, controlling delivery of thevibratory mechanical stimulus based at least in part on the sensedsignal includes modulating delivery of the neural stimulus in responseto the sensed signal, or delivering the vibratory mechanical stimulus inresponse to the sensed signal. In an aspect, controlling the delivery ofthe vibratory mechanical stimulus based at least in part on the sensedsignal includes initiating delivery of the vibratory mechanical stimulusin response to the sensed signal.

In an aspect, method 1100 includes receiving a signal from an input andcontrolling the delivery of the vibratory mechanical stimulus based atleast in part on the received signal, as indicated at 1108. The receivedsignal may be e.g., any of the various types of input signals receivedat secondary signal input 800 in FIG. 10.

In an aspect, method 1100 includes sensing at least one second sensedsignal with a second sensor and controlling the delivery of thevibratory mechanical stimulus based at least in part on the secondsensed signal, as indicated at 1110.

In an aspect, method 1100 also includes delivering a secondary stimulusto the subject, as indicated at 1112, which may include delivering asecondary stimulus with a secondary stimulator 818, as described inconnection with FIG. 7.

As discussed in connection with method 900, the vibratory mechanicalstimulus can be delivered in response to detection of symptoms of abrain-related disorder, which may include, for example, a mental healthdisorder, depression, post-traumatic stress disorder, seasonal affectivedisorder, anxiety, headache, or epilepsy. In an aspect, method 1100includes delivering the vibratory mechanical stimulus until symptoms ofthe brain-related disorder are no longer detected.

FIG. 12 depicts a neural stimulation system 1200 which includes awearable neural stimulation device 1202 and personal computing device1204. Personal computing device 1204 may be packaged separately fromwearable neural stimulation device 1202, e.g., similar to the systemdepicted in FIGS. 2A and 2B. Wearable neural stimulation device 1202includes neural stimulator 706, which is adapted to produce a stimulusfor activating at least one sensory nerve fiber innervating at least aportion of a pinna of a subject, securing member 710 configured tosecure the neural stimulator to the pinna, control circuitry 1206 forcontrolling operation of neural stimulator 706, and first communicationcircuitry 1208. Neural stimulator 706 and securing member 710 are asdescribed herein above in connection with FIG. 7. Both control circuitry1206 and first communication circuitry 1208 are incorporated into thewearable neural stimulation device 1202. First communication circuitry1208 is operatively connected to control circuitry 1206 and isconfigured for at least one of sending a signal 1210 to and receiving asignal 1212 from personal computing device 1204. Other system componentsthat may be included in or used in connection with wearable neuralstimulation device 1202 include secondary signal input 800, secondarystimulator 818, sound source 856, position sensor 864 and connector 866,as described herein above in connection with FIG. 7, and sensor 1018 asdescribed herein above in connection with FIG. 10. In an aspect, neuralstimulation system 1200 includes user interface 1221, including userinput device 1222 which is used to receive an input from the subject orother user, and user output device 1223. User input device 1222 may beany of various types of user input devices known to those of ordinaryskill in the art, including but not limited to a button, keyboard,keypad, touchscreen, voice input, etc. In system 1200 and in otherneural stimulation systems described herein, system components such assecondary signal input 800, secondary stimulator 818, sound source 856,position sensor 864, connector 866, sensor 1018, and user input device1221 may in some cases be built into the wearable neural stimulationdevice (e.g., wearable neural stimulation device 1202) and in some casesbe packaged separately but used in combination with the wearable neuralstimulation device. For example, sensors may be located on the subject'sbody at a location other than the ear, or in the vicinity of the subjectbut not on the subject's body. In some cases, sensors may be implantedwithin the subject's body. Similarly, one or both of a secondarystimulator and a sound source can be located on the wearable neuralstimulation device, on the subject's body distinct from the neuralstimulation device, or in the vicinity of the subject but not on thesubject's body.

Personal computing device 1202 includes a user interface 1214 for atleast one of presenting information to and receiving information from auser, control circuitry 1216 operatively connected to user interface1214, and second communication circuitry 1218 configured for at leastone of sending a signal to and receiving a signal from the firstcommunication circuitry 1208 carried by the housing of the wearableneural stimulation device. In addition, personal computing device 1202includes instructions 1220 that when executed on personal computingdevice 1204 cause personal computing device 1204 to perform at least oneof sending signal 1212 to and receiving signal 1210 from wearable neuralstimulation device 1202 via second communication circuitry 1218.

Communication circuitry 1208 and communication circuitry 1218 providefor communication between wearable neural stimulation device 1202 andpersonal computing device 1204. In addition, in some aspects one or bothof communication circuitry 1208 and communication circuitry 1218 providefor communication of wearable neural stimulation device 1202 or personalcomputing device 1204, respectively, with a remote system 1224. In someaspects, communication circuitry 1208 and communication circuitry 1218provide for wired communication between wearable neural stimulationdevice and personal computing device 1204. Wired communication towearable neural stimulation device may occur via connector 866.Alternatively, or in addition, a wireless communication link may beestablished between wearable neural stimulation device 1202 and personalcomputing device 1204, and/or between either wearable neural stimulationdevice 1202 or personal computing device 1204 and remote system 1224. Invarious aspects, a wireless communication link includes at least one ofa radio frequency, wireless network, cellular network, satellite, WiFi,BlueTooth, Wide Area Network, Local Area Network, or Body Area Networkcommunication link. Various types of communication links are suitablefor providing communication between two remote locations. Communicationbetween locations remote from each other may take place overtelecommunications networks, for example public or private Wide AreaNetwork (WAN). In general, communication between remote locations is notconsidered to be suitably handled by technologies geared towardsphysically localized networks, e.g., Local Area Network (LAN)technologies operation at Layer 1/2 (such as the forms of Ethernet orWiFi). However, it will be appreciated that portions (but not theentirety) of communication networks used in remote communications mayinclude technologies suitable for use in physically localized network,such as Ethernet or WiFi.

In an aspect, personal computing device 1204 is personal digitalassistant 1226, a personal entertainment device 1228, a mobile phone1230, a laptop computer 1232, a tablet personal computer 1234, awearable computing device 1236 (e.g., a fitness band, an item ofclothing, attire, or eyewear incorporating computing capability), anetworked computer 1238, a computing system comprised of a cluster ofprocessors 1240, a computing system comprised of a cluster of servers1242, a workstation computer 1244, and/or a desktop computer 1246. Invarious aspects, personal computing device 1204 includes one or more ofa portable computing device, a wearable computing device, a mobilecomputing device, and a thin client computing device, for example.

FIG. 13 depicts aspects of a system 1300 including personal computingdevice 1302, for use in connection with neural stimulation system 1303,which is a neural stimulation system such as described herein above.Personal computing device 1302 is as described generally in connectionwith FIG. 12. In an aspect, personal computing device 1302 includescircuitry 1304 for receiving a neural activity signal 1306, circuitry1308 for determining a neural stimulus control signal 1310 based atleast in part on neural activity signal 1306, and circuitry 1312 foroutputting neural stimulus control signal 1310 to neural stimulationdevice 1314. In an aspect, neural activity signal 1306 is sensed byneural signal sensor 1315, and is indicative of a physiological statusof a subject. Neural activity signal 1306 may be an unprocessed neuralsignal, or neural activity signal 1306 may have been subjected tovarious types and amounts of signal processing, and/or analysis(including, but not limited to filtering, amplification, analog todigital conversion, signal averaging, conversion from time to frequencydomain, feature extraction, and so forth). Neural activity signal 1306may include neural activity sensed from one or more neural signalsensors 1315 (which may be electroencephalographic sensors orelectrooculographic sensors, for example). Neural activity signal 1306may include information derived from or associated with the sensedneural signal, and may include or be accompanied by additionalinformation that identifies the type of signal, type of processing towhich the signal has been subject, data formatting, device settings usedduring acquisition of the neural signal, etc. Neural signal sensor 1315is a component of neural stimulation system 1303, and may be a componentof neural stimulation device 1314, or used in association therewith, asdescribed herein above. Neural stimulation device 1314 includes externalneural stimulator 1316, which is configured to be carried on a pinna ofthe subject. Neural stimulus control signal 1310 is configured tocontrol delivery of a neural stimulus by external neural stimulator1316, the neural stimulus configured to activate at least one sensorynerve fiber innervating at least a portion of the pinna.

Neural activity signal input 1304 (the circuitry for receiving neuralactivity signal 1306) includes, for example, a headphone jack 1318, datainput 1320, wireless receiver 1322, or network connection 1324. Invarious aspects neural activity signal input 1304 includes circuitry forreceiving a signal from a body area network, a local area network, or awide area network.

Neural stimulus control signal determination circuitry 1308 includes oneor more of amplitude determination circuitry 1326 for determining aneural stimulus amplitude, frequency determination circuitry 1328 fordetermining a neural stimulus frequency, waveform determinationcircuitry 1330 for determining a neural stimulus waveform, patterndetermination circuitry 1332 for determining a neural stimulus pattern,or duration determination circuitry 1333 for determining a neuralstimulus duration. In an aspect, personal computing device 1302 includesdata storage circuitry 1334 for storing data on the data storage device,including memory 1336 and circuitry for accessing data stored therein.Memory 1336 may contain stored preprogrammed stimulus patterns andwaveforms as well as neural stimulus parameter values from which neuralstimuli can be computed. In an aspect, system 1300 includes data storagecircuitry 1334 for storing data on personal computing device 1302representing neural stimulus control signal 1338. In an aspect, system1300 includes data storage circuitry 1334 for storing data on personalcomputing device 1302 representing previous neural activity 1340. In anaspect, neural activity prediction circuitry 1342 predicts a futureneural activity signal based on a previous neural activity signal.

In an aspect, system 1300 includes secondary stimulus determinationcircuitry 1344 for determining a secondary stimulus based on neuralactivity signal 1306. In an aspect, secondary stimulus determinationcircuitry 1344 determines the secondary stimulus control signal 1346based on previous neural activity signal 1340.

In an aspect, system 1300 includes reporting circuitry 1348 forproviding a report 1350 to at least one recipient. Reporting circuitry1348 may cause report 1350 to be provided via a user interface 1214 (asdescribed in connection with FIG. 12) or via a computing network(accessed via communication circuitry 1218). In an aspect, report 1350is provided to the subject using the neural stimulation device 1314. Inanother aspect, report 1350 is provided to other parties, for example, amedical care provider, an insurance company, a service provider (e.g., abusiness or other entity that provides services related to the neuralstimulation device or related to monitoring use of the neuralstimulation device). In an aspect, report 1350 is provided to at leastone social media contact (or ‘friend’), or to a peer of the subject,e.g., via a social network. In an aspect, the recipient is a computingsystem, e.g. a computing system used for storing and/or processinghealthcare information. In various aspects, anonymization circuitry 1352is used to provide the report in anonymized form (e.g., with informationidentifying the subject removed therefrom). Reporting circuitry 1326 mayinclude circuitry for including various information in report 1350,e.g., information relating to one or more of neural activity signal 1306or information derived therefrom, neural stimulus control signal 1310,settings for neural stimulation device 1314 or personal computing device1302, stored neural activity data 1340, secondary input signal 1354, andsecondary stimulus control signal 1346. In an aspect, system 1300includes secondary stimulus control signal output circuitry 1356 fordelivering secondary stimulus control signal 1346 to secondarystimulator 1358. Secondary stimulator 1358 can be any type ofstimulator, for example such as secondary stimulator 818 described inconnection with FIG. 7.

In an aspect, system 1300 includes secondary signal input 1360 forreceiving a secondary input signal 1354 at personal computing device1302. In an aspect, neural stimulus control signal determinationcircuitry is configured to determine neural stimulus control signal 1310based at least in part on secondary input signal 1354. Secondary inputsignal may be representative of a physiological parameter of the subjector an environmental parameter of the subject, and may include a signalsensed from a sensor on or associate with neural stimulation device1314, or a sensor in the environment of the subject, and/or parametersor values derived from such sensed signals. In an aspect, the secondaryinput signal is indicative of a user input provided by the subject. Inan aspect, secondary input signal 1354 may be received via user input1362 in user interface 1214.

In an aspect, system 1300 includes circuitry for presenting arecommendation to the subject. The recommendation may be presented tothe subject via user output 1364 of user interface 1214, e.g., via audiooutput 1366 and/or graphical display 1368 or transmitted to neuralstimulation device 1303 and presented via a user interface on neuralstimulation device 1303. In an aspect, system 1300 includesrecommendation receiving circuitry 1370 for receiving recommendation1372 at personal computing device 1302. For example, in an aspectrecommendation receiving circuitry 1370 receives recommendation 1372 viaa computing network. In various aspects, recommendation 1372 is receivedfrom a medical care provider, from an insurance company, a serviceprovider, an advisor, a computation-based system (including, e.g. anartificial intelligence), or a social media source, for example. Invarious aspects, recommendation receiving circuitry 1370 is configuredto receive recommendations from particular sources, e.g. by receivingalong with the recommendation a code indicating the source of therecommendation (e.g., a specific medical care provider, a medical careprovider as opposed to a social media source), and to recognize a sourceof the recommendation and respond differently depending upon the sourceof the recommendation. Recommendation receiving circuitry 1370 may beconfigured such that recommendations from more credible sources maypresented to the subject more promptly or more prominently, whereasrecommendations from undesirable sources may be blocked, for example.Recommendation 1372 may relate to a configuration of neural stimuluscontrol signal 1319 or secondary stimulus control signal 1346. In otheraspects, recommendation 1372 relates to one or more of a consumerproduct, a service, a user experience, a user activity, or anorganization that may be of interest to the subject, e.g., because therecommendations would enhance or be compatible with the effects of theneural stimulation received by the subject, or in some other mannerrelate to the neural stimulation or the condition which it is intendedto treat. For example, the recommendation might be for software forstoring, presenting, sharing, or reporting stimulation data or healthdata or for an organization that provides counseling to individuals witha particular condition. In an aspect, user input 1362 is configured toreceive acceptance/rejection signal 1374 from the subject regardingacceptance or rejection of recommendation 1372.

In an aspect, system 1300 includes patch or update receiving circuitry1376 for receiving patch/update 1378 at personal computing device 1302.Patch/update 1378 includes a software patch or update for softwareresiding on personal computing device 1302 or neural stimulation device1314 and may be received, for example, from the manufacturer of neuralstimulation device 1314, from a service provider, or the like. In anaspect, personal computing device 1302 includes update circuitry 1380for applying the patch or update to software installed on personalcomputing device 1302 or to software installed on neural stimulationdevice 1314, by sending update signal 1382 to neural stimulation system1303. In an aspect, update circuitry 1380 also provides for updating aconfiguration of at least one of the neural stimulation device and thepersonal computing device, the configuration relating to operation ofthe neural stimulation device. In an aspect, update circuitry 1380 canbe configured to update the configuration of at least one of the neuralstimulation device and the personal computing device based on historicaldata (e.g., as stored in memory 1336). In another aspect, updatecircuitry 1380 is configured to update the configuration based on atleast one instruction 1384. In an aspect, instruction 1384 is receivedvia user input 1362 of personal computing device 1302. In anotheraspect, instruction 1384 is received from a computing network, (e.g.,from a remote device or system, via a data input such as I/O 892depicted in FIG. 8). In various aspects, instruction 1384 is receivedfrom a medical care provider, an insurance company, or a serviceprovider, for example.

In another aspect, update circuitry 1380 is configured to update theconfiguration of at least one of the neural stimulation device and thepersonal computing device based on at least one recommendation 1372. Asdiscussed herein above, recommendation 1372 is received byrecommendation receiving circuitry 1370, and can be received from anadvisor, from a computation-based system (e.g., an artificialintelligence, machine learning system, or search engine based on adata-driven technique), or from a social media source (for example, invarious aspects, the recommendation is based on the at least onepreference of at least one social media contact, peer, or role model ofthe subject). In addition, acceptance/rejection input 1374 is receivedfrom the subject by user interface 1214 regarding acceptance orrejection of the recommendation, and update circuitry 1380 updates theconfiguration responsive to acceptance of the recommendation by thesubject (if the recommendation is rejected, no update is made inresponse to the recommendation). As an alternative, acceptance orrejection of the recommendation can be provided by a caregiver of thesubject regarding received via either user interface 1214 or via a datainput from a remote device or system. Update circuitry 1380 updates theconfiguration responsive to acceptance of the recommendation by thecaregiver of the subject. In another aspect, update circuitry 1380 isconfigured to update the configuration of at least one of the neuralstimulation device and the personal computing device based on anenvironmental parameter (based in a secondary input signal 1354 receivedat secondary signal input 1360. In another aspect, update circuitry 1380is configured to update the configuration of at least one of the neuralstimulation device and the personal computing device automatically. Forexample, in an aspect, the configuration is updated automaticallyaccording to a schedule, for example when the time and/or date indicatedby clock/timer 1386 matches an update time/date in schedule 1388 storedin memory 1336.

In an aspect, neural activity signal input 1304 includes circuitry forreceiving neural activity signal 1306 via a secure connection. In anaspect, neural control signal output 1312 includes circuitry foroutputting neural stimulus control signal 1346 via a secure connection.The secure connection may include be provided through the use of anencrypted signal, for example.

In an aspect, system 1300 includes output circuitry 1390 for presentinginformation to the subject via user interface 1214, including e.g.,audio output 1366, graphical display 1368, alphanumeric display 1392,touchscreen 1394, or other user interface devices, as known to those ofordinary skill in the art.

In an aspect, system 1300 includes customization circuitry 1396.Customization circuitry 1396 customizes for the subject one or both ofthe information, or the formatting of the information, that is presentedto via user interface 1214, based on user preferences, for example.

In an aspect, system 1300 includes authentication circuitry 1398 forreceiving a credential 1400 showing that the subject is an authorizeduser. In an aspect, output circuitry 1390 presents information to thesubject via user interface 1214 only following receipt of credential1400 showing that the subject is an authorized user. In various aspects,authentication circuitry 1398 receives a password, a personalidentification number, a biometric feature, or a card authentication,for example.

In an aspect, output circuitry 1390 includes output format circuitry1402 for presenting the information to the subject via user interface1214 in a graphical format that mimics the graphical format of an audioplayer, in a graphical format that mimics the graphical format of amobile phone, or in any other graphical format that mimics the graphicalformat of a familiar user interface. This permits the subject to use theneural stimulation device discretely, and present to observers theimpression that the personal computing device is functioning as a mobilephone or audio player rather than being used in connection with a neuralstimulation device. In an aspect, output circuitry 1390 changes ordiscontinues the presenting of information to the subject via the userinterface in response to an input signal 1404. For example, outputcircuitry 1390 switches between a first graphical format and a secondgraphical format on user interface 1214 in response to input signal1404. For example, the first graphical format may present informationrelating to the neural stimulus, while the second graphical format maymimic the format of a mobile phone or audio player. In an aspect, inputsignal 1404 is a user input signal, received for example via userinterface 1214. In another aspect, input signal 1404 is a sensedenvironmental signal indicative of presence of another person (e.g., anaudio input signal containing the detected voice of the other person,received via secondary input signal 1354). In an aspect, input signal1404 is indicative of a time (e.g., a signal received from clock/timer1386 on personal computing device 1302).

In an aspect, neural stimulus control signal determination circuitry1308 modulates neural stimulus control signal 1310 in response to anoverride signal. For example, in an aspect override signal is inputsignal 1404 received via user input 1362. In an aspect, override signalis secondary input signal 1354, received via secondary signal input1360. In an aspect, the override signal originates from a sensor thatsenses a physiological parameter, such as heart rate. In the event thatthe physiological parameter indicates an unsafe condition (e.g., theheart rate is too high or too low), the neural stimulus control signaldetermination circuitry 1308 modulates neural stimulus control signal1310 to discontinue production of the neural stimulus. For example, invarious aspects, the override signal originates from a sensor responsiveto sensing a presence of a person other than the subject in the vicinityof the subject or responsive to sensing that the external neuralstimulator is not properly positioned on the pinna of the subject. In anaspect, neural stimulus control signal determination circuitry 1308modulates neural stimulus control signal 1310 to discontinue productionof the neural stimulus. In an aspect, neural stimulus control signaldetermination circuitry 1308 modulates neural stimulus control signal1310 to change an intensity of the neural stimulus. In addition tomodulating or discontinuing the neural stimulus in response to anoverride condition (e.g., physiological parameter indicative of anunsafe condition, improper positioning of the external neuralstimulator, etc.), a notification may be sent to the subject and/or to amedical care provider or other party regarding the override condition,to prompt the recipient of the notification to take corrective action,or for inclusion of the information in the subject's medical records.

In an aspect, secondary signal input 1360 is adapted to receive aposition signal indicative of a position of the external neuralstimulator with respect to the pinna of the subject. In connectiontherewith, system 1300 may also include notification circuitry 1406 fordelivering a notification to the subject indicating that the externalneural stimulator should be repositioned. In an aspect, notificationcircuitry 1406 includes circuitry for delivering the notification via agraphical display 1368 of personal computing device 1302. In an aspect,notification circuitry 1406 includes circuitry for delivering anauditory alert, either via audio output 1366 of personal computingdevice, or by generating an appropriate audio output signal 1408 fordriving production of the auditory alert by a sound source 1410 onneural stimulation device 1314. In an aspect, notification circuitry1406 includes circuitry for delivering a voice message (e.g., a presetmessage retrieved from memory 1336). In a further aspect, notificationcircuitry 1406 includes circuitry for storing information indicatingthat stimulator 1316 is improperly positioned in a data storage location(e.g., memory 1336) in personal computing device 1302. In anotheraspect, notification circuitry 1406 provides for storing informationindicating that stimulator 1316 is improperly positioned in a datastorage location in neural stimulation device 1314 (e.g., bytransmitting such information to neural stimulation device 1314.

In an aspect, system 1300 includes circuitry for outputting an audiooutput signal, either via an audio output 1366 of personal computingdevice 1302 or via sound source 1410 of neural stimulation device 1314,where the audio output signal drives delivery of sound to the ear of thesubject via a sound source. In an aspect, output circuitry 1390 is usedto output the audio output signal via audio output 1366 of the personalcomputing device. In an aspect, communication circuitry 1218 is used fortransmitting audio output signal 1408 to a sound source 1410 on neuralstimulation device 1314. Alternatively, communication circuitry 1218 canbe used to deliver an audio output signal to sound source distinct fromthe neural stimulation device (e.g., a sound source included in a deviceused by the subject, but not included in the neural stimulation device).In an aspect, output circuitry 1390 retrieves an audio signal from adata storage location (e.g., memory 1336) on personal computing device1302, and generate audio output signal based on the retrieved audiosignal. In another aspect, system 1300 includes audio receiver 1412 forreceiving audio input signal 1414 from a telecommunication network. Forexample, in various aspects, audio input signal 1414 is a broadcastradio signal, a webcast audio signal, or a mobile phone signal.

In an aspect, system 1300 includes prioritization circuitry 1416 forprioritizing delivery of the neural stimulus control signal relative tothe audio output signal (either audio output signal 1408 for delivery tosound source 1410, and/or an audio output signal delivered via audiooutput 1366 on personal computing device 1302). In an aspect,prioritization circuitry 1416 automatically discontinues outputting ofthe neural stimulus control signal 1310 and starts outputting of theaudio output signal in response to receipt of audio input signal 1414.In another aspect, prioritization circuitry 1416 automatically declinesaudio input signal 1414 if the neural stimulus is currently beingdelivered. In another aspect, prioritization circuitry 1416 provides forcircuitry for outputting the audio output signal simultaneously withneural stimulus control signal 1310. In another aspect prioritizationcircuitry 1416 provides for switching between outputting the audiooutput signal and outputting neural stimulus control signal 1346.Switching may occur in response to a user input received via user input1362, or in response to sensor input received, for example, viasecondary signal input 1360. In an aspect, prioritization circuitry 1416performs switching between outputting the audio output signal andoutputting neural stimulus control signal 1310 according to a schedule(stored, e.g., in memory 1336) in response to input from clock/timer1386. In an aspect, prioritization circuitry 1416 switches betweenoutputting the audio output signal and outputting the neural stimuluscontrol signal responsive to receipt of the audio input signal 1414 froma telecommunication network. Prioritization circuitry 1416 may beconfigured to give higher priority to outputting of the neural stimuluscontrol signal than to outputting of the audio output signal, or to givehigher priority to outputting of the audio output signal than tooutputting of the neural stimulus control signal. The priority of thesignals may be determined by the preference of the subject. For example,the subject may consider it a higher priority to receive a phone callvia his or her mobile phone than to continue received of a neuralstimulation, and therefore may configure system 1300 so that neuralstimulation is discontinued when a phone call is received.Alternatively, the subject may prefer that a neural stimulation sessionnot be interrupted, and may configure system 1300 such that no phonecalls will be received while neural stimulation is taking place. Inother aspects, the subject may provide an input at user interface 1214(e.g., by pressing a button) to switch between receiving neuralstimulation and listening to music, as preferred. In another aspect,system 1300 is configured to deliver neural stimulation in combinationwith music.

FIG. 14 is a flow diagram of a method 1450 relating to use of a systemincluding a personal computing device, as illustrated in FIG. 13. Method1450 includes receiving a neural activity signal at a personal computingdevice, the neural activity signal indicative of a physiological statusof a subject, as indicated at 1452. In addition, method 1450 includesdetermining a neural stimulus control signal based at least in part onthe neural activity signal, as indicated at 1454, and outputting theneural stimulus control signal from the personal computing device to aneural stimulation device including an external neural stimulatorconfigured to be carried on a pinna of the subject, wherein the neuralstimulus control signal is configured to control delivery of a neuralstimulus by the external neural stimulator, the neural stimulusconfigured to activate at least one sensory nerve fiber innervating atleast a portion of the pinna, as indicated at 1456. In an aspect,determining the neural stimulus control signal includes determining astimulation pattern. In various aspect, method 1450 includes additionalsteps, relating to the system functions described in greater detail inconnection with FIG. 13. For example, in an aspect, method 1450 includesproviding a report to at least one recipient, as indicated at 1458. Inan aspect, method 1450 includes determining a secondary stimulus controlsignal adapted to control delivery of a secondary stimulus to thesubject, and delivering the secondary stimulus control signal to asecondary stimulator, as indicated at 1460. For example, in an aspect,the secondary stimulator includes a game device, and the secondarystimulus control signal controls operation of the game device. Inanother aspect, the secondary stimulator includes computing systemconfigured to deliver a virtual therapist experience, and the secondarystimulus control signal controls operation of the virtual therapist. Inanother aspect, the secondary stimulus includes an interactive activitydelivered via a computing device, and the secondary stimulus controlsignal controls operation of the computing device.

In an aspect, method 1450 includes receiving a secondary input signal atthe personal computing device and determining the neural stimuluscontrol signal based at least in part on the secondary input signal, asindicated at 1462. For example, in an aspect the secondary input signalis indicative of a user input provided spontaneously by subject. Othersecondary input signals are described herein above.

In an aspect, method 1450 includes presenting a recommendation to thesubject, as indicated at 1464. Method 1450 may also include receivingthe recommendation at the personal computing device, as described abovein connection with FIG. 13.

In an aspect, method 1450 includes receiving a patch or update at thepersonal computing device, the patch or update relating to operation ofthe neural stimulation device, as indicated at 1466. In an aspect, thepatch or update is for software installed on the personal computingdevice. In another aspect, the patch or update is for software installedon the neural stimulation device, in which case method 1450 may alsoinclude sending the patch or update to the neural stimulation device.

In an aspect, method 1450 includes updating a configuration of at leastone of the neural stimulation device and the personal computing device,the configuration relating to operation of the neural stimulationdevice, as indicated at 1468. As discussed above, the configuration isupdated based on at least one instruction. In another aspect, theconfiguration is updated based on at least one recommendation,responsive to receipt of an input regarding acceptance of therecommendation by the subject or a caregiver of the subject.

In an aspect, method 1450 includes presenting information to the subjectvia a user interface, as indicated at 1470. The method may also includechanging or discontinuing the presenting of information to the subjectvia the user interface in response to an input signal. In an aspect,method 1450 includes modulating the neural stimulus control signal inresponse to an override signal, as indicated at 1472.

In an aspect, method 1450 includes receiving a position signalindicative of the position of the external neural stimulator withrespect to the pinna of the subject, as indicated at 1474. Method 1450may also include delivering a notification to the subject indicatingthat external neural stimulator should be repositioned. Other methodaspects are discussed in connection with FIG. 13.

FIG. 15 is a block diagram of a computer program product 1500 forimplementing a method as described in connection with FIG. 14. Computerprogram product 1500 includes a signal-bearing medium 1502 bearing oneor more instructions for receiving a neural activity signal, the neuralactivity signal indicative of a physiological status of a subject; oneor more instructions for determining a neural stimulus control signalbased at least in part on the neural activity signal; and one or moreinstructions for outputting the neural stimulus control signal to aneural stimulation device including an external neural stimulatorconfigured to be carried on a pinna of the subject, wherein the neuralstimulus control signal is configured to control delivery of a neuralstimulus by the external neural stimulator, the neural stimulusconfigured to activate at least one sensory nerve fiber innervating atleast a portion of the pinna, as indicated at 1504. Signal-bearingmedium 1502 may be, for example, a computer-readable medium 1506, arecordable medium 1508, a non-transitory signal-bearing medium 1510, ora communications medium 1512, examples of which are described hereinabove.

FIG. 16 is a block diagram of a system 1600 including a personalcomputing device 1602 and external neural stimulator 1604, whichcomprises a part of neural stimulation device 1606 and neuralstimulation system 1608. Personal computing device 1602 is as describedgenerally in connection with FIG. 12. In an aspect, a system 1600includes personal computing device 1602 including physiological activityinput circuitry 1610 for receiving a physiological activity signal 1612at personal computing device 1062. Physiological activity signal 1612 issensed by physiological sensor 1614 in neural stimulation system 1608,and is indicative of a physiological status of a subject. Physiologicalsensor 1614 can be any of various types of physiological sensors, e.g.,as described in connection with physiological sensor 758 in FIG. 7. Invarious aspects, physiological activity signal 1612 is representative ofa heart rate (and in some cases heart rate rhythm variability), a bloodpressure, perspiration, skin conductivity, respiration, pupil dilation,digestive tract activity, or piloerection. In some aspects,physiological activity signal 1612 is a neural activity signal, such asan electroencephalographic or electrooculographic signal. Physiologicalactivity signal 1612 may be an electromyographic signal (indicative ofmuscle activity of the subject) or an electrocardiographic signal(indicative of cardiac activity of the subject). Physiological activitysignal 1612 may be an unprocessed physiological signal, or physiologicalactivity signal 1612 may have been subjected to various types andamounts of signal processing, and/or analysis (including, but notlimited to filtering, amplification, analog to digital conversion,signal averaging, conversion from time to frequency domain, featureextraction, and so forth). Physiological activity signal 1612 mayinclude activity sensed from one or more physiological sensors 1614.Physiological activity signal 1612 may include information derived fromor associated with the sensed physiological signal, and may include orbe accompanied by additional information that identifies the type ofsignal, type of processing to which the signal has been subject, dataformatting, device settings used during acquisition of the physiologicalsignal, etc. Personal computing device 1602 also includes neuralstimulus control signal determination circuitry 1616 for determiningneural stimulus control signal 1618 based at least in part onphysiological activity signal 1612. Neural stimulus control signal 1618is configured to control delivery of a neural stimulus by externalneural stimulator 1604. In an aspect, the neural stimulus is configuredto activate at least one sensory nerve fiber innervating at least aportion of the pinna. Personal computing device 1602 also includesneural stimulus control signal output circuitry 1620 for outputtingneural stimulus control signal 1618 from personal computing device 1602to neural stimulation device 1606. Neural stimulation device 1606includes external neural stimulator 1604 configured to be carried on apinna of the subject. Personal computing device 1602 also includesoutput circuitry 1390 for presenting information to the subject via userinterface 1364 (as described herein above in connection with FIG. 13).Various elements of system 1600 are the same as like-numbered elementsof the systems shown in FIG. 12 or 13, and accordingly will not bediscussed in detail again in connection with FIG. 16. However, somecomponents of system 1600 include different and/or additional features.For example, data storage circuitry 1334 is also adapted for storingphysiological activity data 1622 representing physiological activitysignal 1612 in memory 1336. In an aspect, physiological activityprediction circuitry 1624 predicts a future physiological activitysignal based on a previous physiological activity signal. In addition,neural stimulus control signal determination circuitry 1616 determinesthe neural stimulus based on a previous physiological activity signal.Secondary stimulus determination circuitry 1344 is adapted to determinethe secondary stimulus based on physiological activity signal 1612 or aprevious physiological activity signal (e.g., stored in memory 1336). Asnoted above in connection with FIG. 13, in an aspect, secondary inputsignal 1354 is a physiological signal. It will be appreciated thatsecondary input signal 1354 in this context will be a secondaryphysiological signal, and physiological activity signal 1612 will be aprimary physiological signal. In an aspect, physiological activity inputcircuitry 1610 includes circuitry for receiving physiological activitysignal 1612 via a secure connection. In an aspect, neural stimuluscontrol signal output 1620 includes circuitry for outputting neuralstimulus control signal 1618 via a secure connection.

FIG. 17 is a flow diagram of a method 1700 relating to use of a systemas depicted in FIG. 16. In an aspect, method 1700 includes receiving aphysiological activity signal at a personal computing device, thephysiological activity signal indicative of a physiological status of asubject, as indicated at 1702; determining a neural stimulus controlsignal based at least in part on the physiological activity signal, asindicated at 1704; outputting the neural stimulus control signal fromthe personal computing device to a neural stimulation device includingan external neural stimulator configured to be carried on a pinna of thesubject, wherein the neural stimulus control signal is configured tocontrol delivery of a neural stimulus by the external neural stimulator,the neural stimulus configured to activate at least one sensory nervefiber innervating at least a portion of the pinna, as indicated at 1706;and presenting information to the subject via a user interface, asindicated at 1708. Other method aspects are discussed in connection withFIGS. 14 and 16.

FIG. 18 is a block diagram of a computer program product 1800 forimplementing a method as described in connection with FIG. 17. Computerprogram product 1800 includes a signal-bearing medium 1802 bearing oneor more instructions for receiving a physiological activity signal, thephysiological activity signal indicative of a physiological status of asubject; one or more instructions for determining a neural stimuluscontrol signal based at least in part on the physiological activitysignal; one or more instructions for outputting the neural stimuluscontrol signal to a neural stimulation device including an externalneural stimulator configured to be carried on an ear of a subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna; and one or moreinstructions for presenting information to the subject via a userinterface, as indicated at 1804. Signal-bearing medium 1802 may be, forexample, a computer-readable medium 1806, a recordable medium 1808, anon-transitory signal-bearing medium 1810, or a communications medium1812, examples of which are described herein above.

FIG. 19 is a block diagram of a system 1900. FIG. 19 is similar to thesystem depicted in FIGS. 13 and 16, and like-numbered system componentsdescribed in connection with these figures will not be described againin connection with FIG. 19. In an aspect, system 1900 includes apersonal computing device 1902 including physiological activity inputcircuitry 1610 for receiving a physiological activity signal at personalcomputing device 1902, the physiological activity signal 1612 indicativeof a physiological status of a subject. System 1900 also includes neuralstimulus control signal determination circuitry 1616 for determining aneural stimulus control signal 1618 based at least in part onphysiological activity signal 1612. In addition, system 1900 includesneural stimulus control signal output circuitry 1620 for outputtingneural stimulus control signal 1618 from personal computing device 1902to neural stimulation device 1904. Neural stimulation device 1904includes external neural stimulator 1604 configured to be carried on apinna of the subject, wherein neural stimulus control signal 1618 isconfigured to control delivery of a neural stimulus by the externalneural stimulator, the neural stimulus configured to activate at leastone sensory nerve fiber innervating at least a portion of the pinna.System 1900 also includes audio output circuitry 1908 for outputting anaudio output signal 1910 via an audio output 1366 of personal computingdevice 1902. In an aspect, system 1900 includes circuitry for deliveringthe audio output signal to sound source 1910 on neural stimulationdevice. In another aspect, system 1900 includes circuitry for deliveringaudio output signal 1910 to sound source 1912 that is distinct fromneural stimulation device 1904. For example, sound source 1912 may be asound source in the environment of the subject but not on the neuralstimulation device, including but not limited to a sound source on,built into, or associated with personal computing device 1902. In anaspect, system 1900 includes data storage circuitry 1334 for retrievingstored audio signal 1914 from a data storage location (memory 1336) onpersonal computing device 1902. In an aspect, system 1900 includes audioreceiver 1412 for receiving the audio input signal fromtelecommunication network 1918. For example, in various aspects, theaudio input signal is a broadcast radio signal 1920, a webcast audiosignal 1922, or a mobile phone signal 1024.

In an aspect, system 1900 includes prioritization circuitry 1416 whichprioritizes between delivery of neural stimulus and delivery of theaudio output signal, based upon system settings and/or preferences ofthe subject. For example, prioritization circuitry 1416 provides forautomatically discontinuing outputting of the neural stimulus controlsignal and starting outputting of the audio output signal in response toreceipt of the audio input signal, automatically declining the audioinput signal if the neural stimulus is currently being delivered, oroutputting the audio output signal simultaneously with the neuralstimulus control signal. In other aspects, prioritization circuitry 1416provides switching between outputting the audio output signal andoutputting the neural stimulus control signal, for example in responseto a user input or a sensor input, according to a schedule, or inresponse to receipt of an audio input signal (e.g., a phone call) from atelecommunication network. Depending on preference of the subject orother considerations, prioritization circuitry 1416 can be configured togive higher priority to outputting of the neural stimulus control signalthan to outputting of the audio output signal, or to give higherpriority to outputting of the audio output signal than to outputting ofthe neural stimulus control signal.

FIG. 20 is a flow diagram of a method 2000 relating to use of a systemas depicted in FIG. 19. In an aspect, method 2000 includes receiving aphysiological activity signal at a personal computing device, thephysiological activity signal indicative of a physiological status of asubject, as indicated at 2002; determining a neural stimulus controlsignal based at least in part on the physiological activity signal, asindicated at 2004; outputting the neural stimulus control signal fromthe personal computing device to a neural stimulation device includingan external neural stimulator configured to be carried on a pinna of thesubject, wherein the neural stimulus control signal is configured tocontrol delivery of a neural stimulus by the external neural stimulator,the neural stimulus configured to activate at least one sensory nervefiber innervating at least a portion of the pinna, as indicated at 2006;and outputting an audio output signal via an audio output of thepersonal computing device, as indicated at 2008. Other method aspectsare discussed in connection with FIGS. 14 and 19.

FIG. 21 is a block diagram of a computer program product 2100 forimplementing a method as described in connection with FIG. 20. Computerprogram product 2100 includes a signal-bearing medium 2102 bearing oneor more instructions for receiving a physiological activity signal at apersonal computing device, the physiological activity signal indicativeof a physiological status of a subject, one or more instructions fordetermining a neural stimulus control signal based at least in part onthe physiological activity signal, one or more instructions foroutputting the neural stimulus control signal from the personalcomputing device to a neural stimulation device including an externalneural stimulator configured to be carried on a pinna of the subject,wherein the neural stimulus control signal is configured to controldelivery of a neural stimulus by the external neural stimulator, theneural stimulus configured to activate at least one sensory nerve fiberinnervating at least a portion of the pinna, and one or moreinstructions for outputting an audio output signal via an audio outputof the personal computing device, as indicated at 2104. Signal-bearingmedium 2102 may be, for example, a computer-readable medium 2106, arecordable medium 2108, a non-transitory signal-bearing medium 2110, ora communications medium 2112, examples of which are described hereinabove.

FIG. 22 is a block diagram of a system 2200, which includes a personalcomputing device 2202 for use in combination with a wearable mechanicalstimulation device 2204. FIG. 22 is similar to the systems depicted inFIGS. 13, 16 and 19 and like-numbered system components described inconnection with these figures will not be described again in connectionwith FIG. 22. Personal computing device 2202 includes vibratory stimuluscontrol signal determination circuitry 2206 for determining a vibratorystimulus control signal 2208, and vibratory stimulus control signaloutput circuitry 2210 for outputting vibratory stimulus control signal2208 to wearable mechanical stimulation device 2204. Wearable mechanicalstimulation device 2204 includes a vibratory mechanical stimulator 1002configured to be carried on a pinna of a subject, wherein the vibratorystimulus control signal is configured to control delivery of a vibratorystimulus by the vibratory mechanical stimulator 1002, the vibratorystimulus configured to activate at least one mechanoreceptor with areceptive field on at least a portion of the pinna. In an aspect,wearable mechanical stimulation device 2204 is a wearable neuralstimulation device 1000 of the type discussed in connection with FIG.10, and can be considered a variant of wearable neural stimulationdevice 1202 depicted and discussed in connection with FIG. 12. Inaddition, in various aspects system 2200 includes additional componentssuch as are included in neural stimulation system 1200 described inconnection with FIGS. 7, 10 and/or 12, including, but not limited to,sensor 1018 for detecting input signal 1354, user interface 1221,position sensor 864, secondary stimulator 818, and sound source 856.Personal computing device 2202 can be any of the various types ofpersonal computing devices described in connection with FIG. 12, forexample, a personal digital assistant, a personal entertainment device,a mobile phone, a laptop computer, a table personal computer, a wearablecomputing device, a networked computer, a computing system comprised ofa cluster of processors, a computing system comprised of a cluster ofservers, a workstation computer, or a desktop computer. Data storagecircuitry 1334 including memory 1336 on personal computing device 2202can be used to store data, instructions, parameters, as describedelsewhere herein, including but not limited to stimulation patterns 2212a, 2212 b, and 2212 c representing vibratory mechanical stimuli to bedelivered under the control of vibratory stimulus control signal 2208.In an aspect, vibratory stimulus control signal 2208 is configured tocause delivery of one of a plurality of pre-programmed stimulationpatterns, e.g., selected from stimulation patterns 2212 a, 2212 b, and2212 c stored in memory 1336. In an aspect, vibratory stimulus controlsignal 2208 is determined by vibratory stimulus control signaldetermination circuitry 2206. In various aspects, vibratory stimuluscontrol signal determination circuitry 2206 includes amplitudedetermination circuitry 2214, frequency determination circuitry 2216,waveform determination circuitry 2218, pattern determination circuitry2220, or duration determination circuitry 2222 for determining variousaspects of the vibratory stimulus control signal 2208, which determinesthe mechanical stimulus delivered by vibratory mechanical stimulator1002. If position signal 2224 from position sensor 864 indicates thatvibratory mechanical stimulator 1002 is not properly positioned on theear of the subject, a notification is provided to the subject, e.g., vianotification circuitry 1406, instructing the subject to repositionvibratory mechanical stimulator 1002.

FIG. 23 is a flow diagram of a method 2300 involving the use of a systemas depicted in FIG. 22. In an aspect, method 2300 includes determining avibratory stimulus control signal with stimulation control circuitry ina personal computing device, as indicated at 2302; and outputting thevibratory stimulus control signal from the personal computing device toa wearable mechanical stimulation device including a vibratorymechanical stimulator configured to be carried on a pinna of a subject,wherein the vibratory stimulus control signal is configured to controldelivery of a vibratory stimulus by the vibratory mechanical stimulator,the vibratory stimulus configured to activate at least onemechanoreceptor with a receptive field on at least a portion of thepinna, as indicated at 2304.

FIG. 24 is a block diagram of a computer program product 2400 forimplementing a method as described in connection with FIG. 23. Computerprogram product 2400 includes a signal-bearing medium 2402 bearing oneor more instructions for determining a vibratory stimulus control signalconfigured to control delivery of a vibratory stimulus by a vibratorymechanical stimulator, the vibratory stimulus configured to activate atleast one mechanoreceptor with a receptive field on at least a portionof a pinna of a subject, and one or more instructions for outputting thevibratory stimulus control signal to a wearable mechanical stimulationdevice including the least one vibratory mechanical stimulator, asindicated at 2404. Signal-bearing medium 2402 may be, for example, acomputer-readable medium 2406, a recordable medium 2408, anon-transitory signal-bearing medium 2410, or a communications medium2412, examples of which are described herein above.

In some aspects, wearable neural stimulation devices and systems asdescribed herein above are used in combination with remote systems. Forexample, FIGS. 2A and 2B illustrate a neural stimulation system used incombination with remote system 26, via communication network 218. FIG.12 depicts communication between wearable neural stimulation device 1202and/or personal computing device 1204, which form neural stimulationsystem 1200, and remote system 1224. In addition, as shown in FIG. 13,information may be transmitted to personal computing device 1302 from aremote system, including, for example, recommendation 1372, patch/update1374, or instruction 1384. FIG. 25 provides greater detail regardingsuch a remote system 2500. Remote system 2500 includes computing system2502. Computing system 2502 includes identification circuitry 2504 forreceiving identifying information 2506 identifying at least one of asubject 2508 and a neural stimulation device 2510 associated withsubject 2508. Neural stimulation device 2510 is a neural stimulationdevice configured to be carried on an ear of a subject and including anexternal neural stimulator 2512. System 2502 includes recommendationcircuitry 2520 for providing a recommendation 2522 relating to atreatment regimen to subject 2508, where the treatment regimen includesdelivery of a neural stimulus to the subject with external neuralstimulator 2512, the neural stimulus configured to activate at least onesensory nerve fiber innervating skin on or in the vicinity of the ear ofthe subject. In an aspect, recommendation circuitry 2520 uses a databaseto generate recommendations for combinations of treatments in thetreatment regimen, for example in a manner similar to that described inU.S. Pat. No. 7,801,686 granted Sep. 21, 2010 to Hyde et al.; U.S. Pat.No. 7,974,787 granted Jul. 5, 2011 to Hyde et al.; U.S. Pat. No.8,876,688 granted Nov. 4, 2014 to Hyde et al.; U.S. Patent Publication2009/0269329 to Hyde et al., dated Oct. 29, 2009; U.S. PatentPublication 2009/0271009 to Hyde et al. dated Oct. 29, 2009; and U.S.Patent Publication 2009/0271375 to Hyde et al. dated Oct. 29, 2009, eachof which is incorporated herein by reference.

In various aspects, neural stimulation device 2510 is a neuralstimulation device of any of the various types described herein, e.g.,in connection with any of FIG. 7, 10, or 12. In an aspect recommendation2522 is sent to, and identifying information 2506 is received from, alocal system 2524. Local system 2524 includes neural stimulation device2510 and other components at the location of subject 2508, including butnot limited to a secondary stimulator 2526, at least one sensor 2528(e.g., an environmental sensor 2530, a physiological sensor 2532, orother sensor as discussed herein above). In an aspect, local system 2524includes personal computing device 2534. Personal computing device 2534may include, for example, at least one of a personal digital assistant,a personal entertainment device, a mobile phone, a laptop computer, atablet personal computer, a wearable computing device, a networkedcomputer, a workstation computer, and a desktop computer, as discussedherein above. In an aspect, recommendation 2522 is presented to subject2508 via a user interface of personal computing device 2534, forexample, and acceptance or rejection of the recommendation entered via auser interface of personal computing device 2534 and transmitted asacceptance/rejection signal 2536 to remote computing system 2502.

Secondary stimulator 2526, sensor 2528, and personal computing device2534 are as described herein above, e.g., in connection with at leastFIGS. 7 and 12. Signals containing information, instructions, data, etc.may be sent between neural stimulation device 2510 and computing system2502 directly, or information may be sent between computing system 2502and personal computing device 2534, and then between personal computingdevice 2534 and neural stimulation device 2510. Transmission of signals(information, instructions, data, etc.) between computing system 2502and local system 2524 may be via wired or wireless communication links,e.g., via computer or communication networks. In an aspect, computingsystem 2502 is part of a computing network from which it receivesinformation 2536 from various parties and/or entities, including but notlimited to social media 2540, social media contacts 2542, peers 2544, orrole models 2546 of subject 2508, insurance companies, service providers(e.g., medical care providers or companies providing various health orwellness related services), and computation-based system associated withsuch service providers, for example.

Computing system 2502 includes one or more computing device, asdescribed generally in connection with FIG. 8. In an aspect, computingsystem 2502 includes update generation circuitry 2560 for generatingpatch/update 2562 which is sent to local system 2524, for updatingsoftware on either personal computing device 2534 or neural stimulationdevice 2510. In an aspect, computing system 2504 includes secondarystimulus determination circuitry 2564 for determining a secondarystimulus to be delivered in combination with the neural stimulus, e.g.,by secondary stimulator 2526. The secondary stimulus may be any ofvarious types of stimuli, as described herein above. In an aspect,computing system 2502 includes data storage circuitry 2566, which invarious aspects stores information regarding, e.g., one or morestimulation patterns 2570, subject response information 2572 received,e.g., from local system 2524, treatment regimen information 2574, or oneor more report 2576. In an aspect, report 2576 is generated by reportingcircuitry 2578 and stored in data storage circuitry 2566 in addition to,or as an alternative to, providing report 2576 to a recipient.

FIG. 26 provides greater detail regarding several aspects of FIG. 25 ofinformation handled by system 2500, specifically information included inidentifying information 2506, recommendation 2522, and treatment regimeninformation 2574.

In various aspects, identifying information 2506 includes deviceinformation 2602 pertaining to the neural stimulation device 2510, orsubject information 2610 pertaining to the subject. Device information2602 includes, for example, device type information 2604, device serialnumber 2606, or device inventory number 2608). Subject information 2610includes, for example, a name of the subject 2612, a user name 2614associated with the subject, an email address 2616 associated with thesubject, a subject identification 2618 (e.g., identification number,code or the like), or biometric information 2620 associated with thesubject. In various aspects, subject identification 2618 can be input bythe subject via a user input, read with a bar-code or RFID reader,received with an RF receiver, etc.

Recommendation 2522 may include one or more recommendations for variousaspects of device and system configuration for delivery of neuralstimulation, and for one or more additional stimuli or experiences to bepresented to or experienced by the subject in association with theneural stimulus. In various aspects, recommendation 2522 is for aconfiguration of the neural stimulus 2622 (e.g., stimulus amplitude2624, frequency 2626, duration 2628, waveform 2630, or delivery pattern2632). In various aspects, recommendation 2522 is for a secondarystimulus 2632 to be delivered in association with the neural stimulus.In various aspects, secondary stimulus 2632 includes music, an auditorystimulus, a video stimulus, a tactile stimulus, a haptic stimulus, anolfactory stimulus, a pharmaceutical, a nutraceutical, a secondaryneural stimulus, an experience (including, but not limited to a virtualreality experience, a game experience, a virtual therapist experience,an augmented reality experience, and/or an interactive experience). Invarious aspects, recommendation 2522 is for a product 2634, a service2636, an activity 2638, an experience 2640, or an organization 2642. Therecommendation may be for multiple experiences. In an aspect, therecommendation specifies a pattern of delivery of the experience(s). Itwill be appreciated that not all secondary stimuli recommended for usein conjunction with a neural stimulus are delivered by the neuralstimulation system. Recommendations (e.g., for a product, service,experience, or organization) can be presented to the subject via thepersonal computing device in the form of a link to a relevant website,so that the subject may conveniently access the recommended product,service, experience, or organization, which the subject does, asdesired.

Treatment regimen information 2574 includes, for example, neuralstimulus information 2650 regarding the neural stimulus, secondarystimulus information 2652 regarding a secondary stimulus delivered inassociation with the neural stimulus, information 2654 regarding asecondary data signal, which may specifically include neural sensorsignal information 2656, physiological sensor signal information 2658,environmental sensor signal information 2660, motion sensor information2662 or location sensor information 2664.

FIG. 27 is a flow diagram of a method 2700 carried out in connectionwith a system as depicted in FIG. 25 for providing recommendations to asubject. In an aspect, a method 2700 includes receiving identifyinginformation at a computing system (e.g., computing system 2502 in FIG.25), the identifying information identifying at least one of a subjectand a neural stimulation device associated with the subject, the neuralstimulation device configured to be carried on an ear of a subject andincluding an external neural stimulator, as indicated at 2702; andtransmitting a recommendation relating to a treatment regimen from thecomputing system to a personal computing device used by the subject(e.g., personal computing device, the treatment regimen includingdelivery of a neural stimulus to the subject with the external neuralstimulator, the neural stimulus configured to activate at least onesensory nerve fiber innervating skin on or in the vicinity of the ear ofthe subject, as indicated at 2704.

In an aspect, receiving the identifying information at the computingsystem includes receiving information transmitted from the personalcomputing device. In an aspect, receiving the identifying information atthe computing system includes receiving information transmitted via acomputing network. In an aspect, receiving the identifying informationat the computing system includes receiving information transmitted via awireless network. In an aspect, providing the recommendation relating tothe treatment regimen to the subject includes transmitting therecommendation to a personal computing device, e.g., via a computingnetwork or a wireless network.

In an aspect, the recommendation is received at the computing systemfrom a medical care provider. In another aspect, the recommendation isgenerated at the computing system, e.g., by recommendation circuitry2520 as shown in FIG. 25. The recommendation can be generated based onvarious types of information: for example, information regarding aresponse of the subject to a past treatment regimen (subject responseinformation 2572 in FIG. 25); information obtained via social media(e.g., information 2536 in FIG. 25) which may include, for example,information regarding one or more preferences of one or more socialmedia contacts, peers, or role models of the subject); information froman insurance company; or information from a service provider. In anaspect, generating the recommendation includes generating therecommendation with a computation-based system 2552 (e.g., an artificialintelligence, machine learning system, or search engine based on adata-driven technique). In an aspect, generating the recommendationincludes generating the recommendation based on a predicted response ofthe subject to a treatment regimen.

In an aspect, method 2700 includes receiving information regardingwhether the subject has accepted or rejected the recommendation. In anaspect, method 2700 includes receiving a credential showing that thesubject is an authorized user of the personal computing device. Forexample, the credential may include a password, a PIN, a biometricfeature, or a card authentication, and/or a credential showing that thepersonal computing device is an authorized device.

In an aspect, method 2700 includes storing at least one parameter of theneural stimulus in a data storage location associated with the computingsystem (e.g., with data storage circuitry 2566 of computing system2502).

In aspect, the recommendation relates to at least one parameter of theneural stimulus, for example, an amplitude, frequency, waveform, orduration of delivery of the neural stimulus, or stimulation pattern fordelivery of the neural stimulus. The stimulation pattern may be, forexample, a preprogrammed pattern, a continuous pattern, an intermittentpattern, a time-varying pattern, and/or a pulsed pattern. In an aspect,the recommendation specifies a selection of one of multiple stimulationpatterns.

In an aspect, receiving the identifying information at the computingsystem includes receiving information transmitted from the personalcomputing device.

In an aspect, method 2700 includes transmitting a report relating to thetreatment regimen to at least one recipient. In an aspect, the at leastone recipient includes, for example, the subject, a caregiver of thesubject, at least one social media contact of the subject, at least onepeer of the subject, at least one medical care provider, or at least oneinsurance provider. In an aspect, the recipient is a computing system,e.g. a computing system used for storing and/or processing healthcareinformation. In some cases the report is anonymized, e.g., to preservethe privacy of the subject. The report may include demographicinformation pertaining to the subject, but not personal identifyinginformation pertaining to the subject, for example. In an aspect,transmitting the report includes transmitting the report to the personalcomputing device. The report may include, for example, a neural stimuluscontrol signal, a determined compliance of the subject with thetreatment regimen, a determined efficacy of the treatment regimen, oneor more system settings for controlling delivery of the neural stimulus,data retrieved from a data storage location associated with thecomputing system, and/or information regarding a secondary stimulusdelivered in association with the neural stimulus. Compliance of thesubject and/or efficacy of the treatment regimen may be determined byquestioning the subject directly, by questioning another party, such asa caregiver, or by making a determination from measured physiologicalparameters of the subject.

In an aspect, method 2700 includes receiving a report relating to thetreatment regimen from the personal computing device. In an aspect,method 2700 includes storing information relating to the treatmentregimen in a data storage location associated with the computing system,e.g., treatment regimen information 2574 as described in connection withFIGS. 15 and 26.

In an aspect, method 2700 includes receiving information at thecomputing system regarding a previously delivered treatment regimen. Inaddition, the method may include receiving information at the computingsystem regarding a response of subject to the previously deliveredtreatment regimen.

In an aspect, method 2700 includes sending a patch or update to apersonal computing device from the computing system. The patch or updatemay be for software installed on the personal computing device, or forsoftware installed on the external neural stimulator.

In an aspect, method 2700 includes generating an update for theconfiguration of the neural stimulus. This may be done based on aresponse of the subject to a previous treatment regimen, based on anenvironmental factor, or based on motion or location of the subject. Inan aspect, the update is generated automatically e.g., when it isdetermined that an update is needed (based on a subject response orsensed environmental factor). In another aspect, the update is generatedbased upon acceptance of a recommendation for the update by the subject.

FIG. 28 is a block diagram of a computer program product 2800 forimplementing a method as described in connection with FIG. 27. Computerprogram product 2800 includes a signal-bearing medium 2802 bearing oneor more instructions for receiving identifying information identifyingat least one of a subject and a neural stimulation device associatedwith the subject, the neural stimulation device configured to be carriedon an ear of a subject and including an external neural stimulator, andone or more instructions for providing a recommendation relating to atreatment regimen to the subject, the treatment regimen includingdelivery of a neural stimulus to the subject with the external neuralstimulator, the neural stimulus configured to activate at least onesensory nerve fiber innervating skin on or in the vicinity of the ear ofthe subject, as indicated at 2804. Signal-bearing medium 2802 may be,for example, a computer-readable medium 2806, a recordable medium 2808,a non-transitory signal-bearing medium 2810, or a communications medium2812, examples of which are described herein above.

FIG. 29 depicts an embodiment of a system 2900 for delivering neuralstimulation in combination with providing a therapeutic secondarystimulus. System 2900 includes securing member 400, of the type depictedin FIGS. 4A and 4B, with an ear canal insert 416 including a heart ratesensor (not shown in FIG. 29), and stimulating electrodes 414 a and 414b, positioned to stimulate pinna 2902 of subject 2904. System 2900 alsoincludes mobile phone 2906, configured with application software 2908.Mobile phone 2906 and application software 2908 together form at leastphysiological activity input circuitry 2910, secondary signal input2912, neural stimulus control signal determination circuitry 2914,secondary stimulus determination circuitry 2916, and reporting circuitry2918. Mobile phone 2906 along with application software 2908 form apersonal computing device, which includes a variety of circuitry (notall of which is depicted in FIG. 29), e.g. as depicted and described inconnection with FIG. 16.

Neural stimulus control signal determination circuitry 2914 is used togenerate neural stimulus control signal 2920, which drives delivery of aneural stimulus via electrodes 414 a and 414 b. Secondary stimulusdetermination circuitry 2916 is used to generate secondary stimuluscontrol signal 2922, which controls delivery of the therapeuticsecondary stimulus while subject 2904 is receiving stimulation deliveredto pinna 2902. In the example of FIG. 29, the therapeutic secondarystimulus is provided via digital media, in the form of a therapyapplication that provides cognitive training and therapy. The therapyapplication also performs mental health monitoring. In an aspect, thetherapy application includes an interactive survey 2924 displayed ontouchscreen 2926 of mobile phone 2906. The survey asks subject 2904questions designed, for example, to assess the subject's mental oremotional state (“Rate how you feel today”), identify factorscontributing to or relating to the subject's mental or emotional state(“Did you sleep well last night?”), and guide the subject towardpositive and/or constructive thought patterns (“What did you enjoytoday?”). Subject 2904 provides responses (user input 2930) to thequeries via touchscreen 2926, which are received by secondary signalinput 2912. In addition, or as an alternative, the therapy applicationmay provide a therapeutic secondary stimulus that includes music orguided meditation, delivered via touchscreen 2926 and/or a speaker inear canal insert 416.

Heart rate 2932, sensed with a heart rate sensor (for example an ECGsensor or pulse oximeter sensor) in ear canal insert 416, is provided tophysiological activity input circuitry 2910. The subject's heart rate ismonitored during delivery of neural stimulation in combination with thetherapeutic secondary stimulus, to track the effect of the stimulationand therapy over time. Amount of heart rate variability and duration ofheart variability and/or changes in heart rate variability over time maybe monitored. Heart rate variability is an indicator of the balancebetween sympathetic and parasympathetic tone. Increased heart ratevariability is associated with reduced inflammation and anxiety. Inaddition, the physiologic data can be coupled with how the subjectinteracts with the program. In an aspect, one or both of neural stimuluscontrol signal 2920 and secondary stimulus control signal 2922 aremodified (by neural stimulus control signal determination circuitry 2914and secondary stimulus determination circuitry 2916, respectively), inresponse to heart rate 2932 and user input 2930. Physiological dataregarding the subject's heart rate as well as data regarding interactionof subject 2904 with application software 2908 can be included in report2934 which can be sent to the subject's medical care provider orpsychologist via network 2936. Detection of a heart rate indicative ofan unsafe condition due to the neural stimulation results indiscontinuation or modulation of stimulation, and transmittal of anotification to the subject's medical care provider.

FIG. 30 is a flow diagram of a method of controlling an ear stimulationdevice with a personal computing device. The ear stimulation device is awearable neural stimulation device as described elsewhere herein (e.g.wearable ear stimulation device 202 controlled with personal computingdevice 208, as depicted in FIGS. 2A and 2B), for delivering a stimulusto an ear of a user of the personal computing device to stimulate atleast one nerve innervating the ear. In an aspect, the ear stimulationdevice includes an earpiece that incorporates a positioning element anda neural stimulator, various examples of which are described anddepicted herein. In an aspect, the ear stimulation device is part of asystem that is used for delivering sound (e.g., music), and the earpieceincludes a speaker or other sound source. In an aspect, the systemincludes a pair of earpieces. In an aspect, only one of the earpiecesincludes a neural stimulator, but both earpieces include a speaker orother sound source. In another aspect, both earpieces include bothneural stimulator and sound source. In another aspect, one earpieceincludes a sound source and the other includes a neural stimulator. Inan aspect, method 3000 in FIG. 30 includes capturing, with image capturecircuitry on the personal computing device, via a user-facing cameraassociated with a personal computing device, an image of a user of thepersonal computing device, as indicated at 3002; processing the image,using image processing circuitry on the personal computing device, todetermine at least one parameter as indicated at 3004; and controlling,with neural stimulus control signal determination circuitry on thepersonal computing device, based at least in part on the at least oneparameter, delivery of a stimulus to at least one nerve innervating anear of the user with the ear stimulation device, as indicated at 3006.

FIGS. 31-33 depict further aspects of the method of FIG. 30, whereinsteps 3002, 3004, and 3006 are as depicted and described in connectionwith FIG. 30. As depicted in FIG. 31, in further aspects of method 3100,the at least one parameter is indicative of at least one emotion of theuser 3102, is indicative of a physiological condition of the user 3104,is indicative of a medical condition of the user 3106, is indicative ofan identity of the user 3108, is a heart rate of the user 3110, isrelated to eye position of the user 3112, is related to eye movement ofthe user 3114 of the user, or is indicative of a position of theearpiece with respect to the ear of the user 3116. Various schemes foridentifying or classifying emotions have been devised, and the meaningof the term, as used herein, is not tied to any specific scheme.Examples of emotions include, but are not limited to, e.g. depression,anxiety, agitation, happiness, sadness, excitement, fear, and anger. Invarious aspects, a physiological condition of the subject is indicativeof a medical condition of the subject. Medical conditions of thesubject, include, for example, muscle spasm, seizure, epilepsy (e.g.,seizure, spasm, staring), drowsiness, lethargy, fatigue, pain, fever,hypertension (e.g., sweating, flushing), hypotension, or mental state.

Determining a parameter indicative of a position of the earpiece withrespect to the ear of the user can include, for example, determining adistance of one or more portion of the earpiece with respect to variousanatomical features of the ear, e.g., the ear canal, the tragus, thehelix, the lobe, etc., to determine whether the earpiece is positionedon the appropriate portion of the pinna or inserted far enough into theear canal, for example. In an aspect, method 3100 further includesdelivering, under control of notification circuitry on the personalcomputing device, a notification to the user informing the user of theneed to adjust a position of an earpiece of the ear stimulation devicewith respect to the ear of the user, as indicated at 3118. In variousaspects, delivering a notification includes delivering a textnotification 3120, delivering a visible notification 3122, or deliveringan audio notification 3124. The notification can be specific (e.g., atext or audio notification instructing the user to “push the earpiecefurther into the ear canal” or “move the earpiece higher up on thepinna”) or non-specific (e.g., a flashing light or beeping sound thatindicates the need to reposition the earpiece without providing detailon how specifically it should be repositioned). In an aspect, deliveringa notification includes delivering a directional notification 3126. Asused herein, the term “directional notification” refers a notificationthat provides information to the user regarding the direction ofmovement needed to move the earpiece to the proper position. Forexample, in an aspect, the notification includes a text or audionotification as described above, which instructs the user to “push theearpiece further into the ear canal” or “move the earpiece higher up onthe pinna.” In another aspect, the notification includes a tone thatchanges in pitch as the earpiece moves toward or away from the properlocation, or a click or other pulsed sound that is repeated at afrequency that changes as the earpiece moves toward or away from theproper location. In an aspect, the tone can change (i.e. changing toanother tone, or stopping entirely) when the earpiece is in the properlocation.

The vagus innervation of the ears is not strictly symmetrical; forexample, the right ear, unlike the left ear, is innervated by a branchof the vagus nerve that, when stimulated, influences heart rate.Accordingly, in some circumstances it may be preferred to stimulate theleft, but not the right ear, to avoid affecting the heart rate of theuser. Therefore, if the system includes two earpieces (e.g., for thepurpose of delivering music or other audio to both the left and rightear), in an aspect, only one of the earpieces includes a neuralstimulator. For example, the earpiece with the neural stimulator is thenconsidered to be usable on the left ear, but not the right ear. In someaspects, the two earpieces are shaped differently such that one fits theleft, but not the right ear and the other fits the right, but not theleft ear. In other aspects, the two earpieces are shaped such that theyfit on either ear. In such a situation, the two earpieces may bedistinguished from each other based on shape or color, or by inclusionof indicia on the earpiece or associated cable, and the ear stimulationdevice control system. A method 3200 as outlined in FIG. 32, which is afurther variant of the method of FIG. 30, can be used in connection withthe ear stimulation device to ensure that the earpiece with the neuralstimulator is used only with the ear with which it is considered to beusable. Method 3200, includes at 3202 the following steps: processingthe image, using the image processing circuitry, to determine (at 3202a) the presence of at least one earpiece of the ear stimulation devicelocated at an ear of the user, as indicated at 3202 b; the ear of theuser at which the at least one earpiece is located, wherein the ear isselected from a right ear of the user and a left ear of the user, asindicated at 3202 c, and at least one attribute of the at least oneearpiece indicative of usability of the at least one earpiece with oneof the left or the right ear of the user, as indicated at 3202 d;determining, using application software on the personal computingdevice, the ear at which the earpiece is usable, based on the at leastone attribute of the at least one earpiece 3202 e; determining, usingapplication software on the personal computing device, whether the earat which the at least one earpiece is located is the ear at which theearpiece is usable 3202 f; and, if the ear at which the at least oneearpiece is located is not the ear at which the earpiece is usable,sending a control signal from the personal computing device to the earstimulation device, under control of the neural stimulus control signaldetermination circuitry, to prevent delivery of a stimulus to the ear atwhich the earpiece is located via the earpiece, as indicated at 3202 g.In a further aspect, method 3200 includes receiving, with handshakecircuitry on the personal computing device, a handshake signal from earstimulation device control circuitry associated with the ear stimulationdevice, as indicated at 3204. This may include capturing the image ofthe user of the personal computing device responsive to receiving thehandshake signal from the ear stimulation device control circuitry, asindicated at 3206. In an aspect, method 3200 includes sending ahandshake signal to the ear stimulation device control circuitryresponsive to determining the presence of the at least one earpiecelocated at the ear of the user in the image, as indicated at 3208.

FIG. 33 depicts method 3300, providing further detail regarding themethod of FIG. 32, with step 3202 in FIG. 33 the same as in FIG. 32. Inan aspect, method 3300 includes delivering, under control ofnotification circuitry on the personal computing device, a notificationto the user informing the user of the need to switch the earpiece to theother ear if the ear at which the at least one earpiece is located isnot the ear at which the earpiece is usable, as indicated at 3302.Delivering the notification to the user may include, for example, one ormore of delivering a text notification, at 3304, delivering a visiblenotification, at 3306, or delivering an audio notification, at 3308. Invarious aspects, determining the at least one attribute 3433 of the atleast one earpiece includes determining a shape of the at least oneearpiece, at 3310, or determining a color of the at least one earpiece,at 3312, for example. In an aspect, determining the at least oneattribute 3433 of the at least one earpiece includes determining thepresence of an indicia on the at least one earpiece or an attachment tothe at least one earpiece, as indicated at 3314. In an aspect, theattachment to the at least one earpiece includes a cable connected tothe at least one earpiece, as indicated at 3316.

An alternative approach to addressing the usability of neuralstimulation with the right ear versus the left ear is to includestimulation electrodes in both earpieces, but send a neural stimuluscontrol signal to cause delivery of a neural stimulus only via one ofthe earpieces (e.g., the left ear). In an aspect, a neural stimuluscontrol signal is sent to only one of the earpieces. In an aspect, thisis done if separate neural stimulus control signal outputs are providedfor the two earpieces. In another aspect, a neural stimulus controlsignal is sent to both earpieces, but causes delivery of stimulus viaonly one of the earpieces. This can be done, e.g., by including earstimulation electrical circuitry in the two earpieces that produces aneural stimulus in response to different neural stimulus controlsignals. For example, the neural stimulus control signal can have one ormore characteristics (e.g., frequency, polarity, activation code) thatcause activation of ear stimulation device control circuitry in one butnot the other of the two earpieces. It is assumed that it is known apriori that a particular earpiece (as identified by the attributedetermined in the user image) will receive and be activated by theneural stimulus control signal.

FIG. 34 is a block diagram of an ear stimulation device control system3400. System 3400 includes a personal computing device 3402; auser-facing camera 3404 associated with the personal computing device,image capture circuitry 3406, image processing circuitry 3408, andneural stimulus control signal determination circuitry 3410. In variousaspects, personal computing device 3402 is a phone, watch, wearabledevice, tablet computer, laptop computer, or desktop computer, forexample.

Image capture circuitry 3406 is adapted to capture an image 3412 of auser of personal computing device 3402 from user-facing camera 3404. Inan aspect, user-facing camera is built into the personal computingdevice. In another aspect, user-facing camera 3404 is connected topersonal computing device via either a wired or wireless connection.Image processing circuitry 3408 is configured to process image 3412,using parameter determination module 3414, to determine at least oneparameter 3416. Neural stimulus control signal determination circuitry3410 is configured to control delivery of a stimulus to at least onenerve innervating an ear of the user with an ear stimulation device3432, based at least in part on the at least one parameter 3416. Invarious aspects, parameter 3416 is indicative of one or more of at leastone emotion of the user, a physiological condition of the user, anidentity of the user, or a heart rate of the user. In an aspect,parameter 3416 is related to an eye position or eye movement of theuser. In an aspect, parameter 3416 is indicative of a position of theearpiece with respect to the ear of the user

In an aspect, image processing circuitry 3408 includes earpiece locationmodule 3418, which is configured to process image 3412 to determine thepresence 3435 of at least one earpiece 3419 of the ear stimulationdevice 3432 located at an ear of the user; the ear of the user at whichthe at least one earpiece is located, the ear selected from a right earof the user and a left ear of the user; and at least one attribute 3433of the at least one earpiece indicative of usability of the at least oneearpiece 3419 with one of the left or the right ear of the user, asdiscussed herein above. Attribute 3433 may be, for example, an indicia3421 used to indicate that the earpiece in question includes a neuralstimulator, for example. In an aspect, neural stimulus control signaldetermination circuitry 3410 is configured (with earpiece location logicmodule 3420) to determine the ear at which the earpiece is usable, basedon the at least one attribute 3433 of the at least one earpiece;determine whether the ear at which the at least one earpiece is locatedis the ear at which the earpiece is usable; and if the ear at which theat least one earpiece is located is not the ear at which the earpiece isusable, send a control signal from the personal computing device to theear stimulation device (neural stimulus control signal 3422 from neuralstimulus control signal output 3424) to prevent delivery of the stimulusto the a least one nerve innervating the ear of the user. As discussedherein above, in some circumstances it may be preferred to stimulate theleft, but not the right ear, for example. Hence, in a system thatincludes two earpieces, the two earpieces may be distinguished from eachother based on shape or color, or by inclusion of indicia on theearpiece or associated cable. In various aspects, indicia include anysort of markings detectable in the image via image processing. Indiciamay include solid colored or patterned markings on an earpiece, or mayinclude a characteristic of the earpiece itself (e.g., the color of thematerial of which the earpiece is made). Indicia may be detectable inthe visible spectrum, or at other wavelengths. In some aspects, indiciamay include text, alphanumeric markings, or symbols. The right and leftears of the user may be identified in user image 3412, using imageprocessing methods, e.g. as described in M. M. Fakhir et al., “FaceRecognition Based on Features Measurement Technique,” 2014 UKSim-AMSS8th European Modelling Symposium, pp. 158-162; U.S. Patent ApplicationPublication No. 2016/0026781 to Boczek et al.; and U.S. PatentApplication Publication No. 2008/0285813 to Holm; each of which isincorporated herein by reference. In some aspects, the position of oneor both ears with respect to the face is determined; in some aspects,the shape and/or features of one or both ears is determined.

In an aspect, ear stimulation device control system 3400 includeshandshake circuitry 3426 adapted to receive a handshake signal 3428 fromear stimulation device control circuitry 3430 associated with the earstimulation device 3432. In an aspect, image capture circuitry 3406 isadapted to capture the image 3412 of the user of the personal computingdevice 3402 responsive to receiving the handshake signal 3428 from theear stimulation device control circuitry 3430. For example, in an aspectexchange of information between the ear stimulation device controlsystem 3400 and ear stimulation device 3432 is initiated after userimage 3412 has been captured and evaluated by image processing circuitry3408, and it has been determined, by earpiece location logic module3420, that the earpiece containing the ear stimulation device has beenplaced on the appropriate ear of the user. Alternatively, if twoearpieces including ear stimulation devices are utilized, the handshakesignal from each earpiece can include an earpiece identification codefor identifying the earpiece. The earpiece identification code andindicia associated with a particular earpiece can be linked in a lookuptable stored in data storage circuitry 3464, for example.

In an aspect, the neural stimulus control signal determination circuitry3410 is configured to send a handshake signal 3434 to ear stimulationdevice control circuitry 3430 responsive to determining the presence3435 of the at least one earpiece located at the ear of the user in theimage.

In an aspect, ear stimulation device control system includes outputdevice 3440, and notification circuitry 3442, which is adapted toprovide a notification via output device 3440 instructing the user of toswitch the earpiece to the other ear if the ear at which the at leastone earpiece is located is not the ear at which the earpiece is usable.For example, output device 3440 may be part of user interface 3444. Inan aspect, output device is adapted to deliver a text notification 3446to the user (e.g., output device includes an LED or LCD display,7-segment display, or other alphanumeric display). In another aspect,output device 3440 is adapted to deliver a visible notification 3448 tothe user, which may include a text display, as described previously, agraphic or symbol presented on a display, or a light that can beilluminated, flashed, etc. to attract the attention of the user. In anaspect, output device 3440 is adapted to deliver an audio notification3450 to the user (e.g., output device 3440 includes a speaker, bell,buzzer, or other audio source for delivering one or both of a verbalnotification or an alarm tone). User interface 3444 may also include oneor more user input 3452, of various types, e.g. as discussed elsewhereherein.

As noted above, image processing circuitry 3408 includes earpiecelocation module 3418, which is configured to process image 3412 todetermine at least one attribute 3433 of the at least one earpiece,where in an aspect the at least one attribute 3433 is indicative ofusability of the at least one earpiece with one of the left or the rightear of the user. In addition, neural stimulus control signaldetermination circuitry 3410 is configured (with earpiece location logicmodule 3420) to determine the ear at which the earpiece is usable, basedon the at least one attribute of the at least one earpiece. In anaspect, the at least one attribute of the at least one earpiece includesa shape of the at least one earpiece, a color of the at least oneearpiece, a presence of an indicia 3421 on the at least one earpiece ora presence of indicia 3421 on an attachment to the at least oneearpiece, where, as noted above, the attachment to the at least oneearpiece may be, for example, a cable connected to the at least oneearpiece. For example, in a system in which only one of two earpiecesincludes a stimulating electrode, the cable connected to the earpiecewith the electrode may include a pattern of light and dark stripes,while the cable connected to the other earpiece may be a solid color. Inembodiments in which two earpieces including ear stimulation devices areused, neural stimulus control signal determination logic can send aneural stimulus control signal 3422 sufficient to activate only anearpiece that is usable with the ear upon which it is located, based onthe output of earpiece location logic module 3420.

In an aspect, image processing circuitry 3408 includes emotiondetermination module 3454, which determines an emotion of the user fromuser image 3412, based upon one or more parameter 3416, e.g. from facialexpression, for example using methods as described in Su, “A simpleapproach to facial expression recognition,” Proceedings of the 2007Int'l Conf on Computer Engineering and Applications, Queensland,Australia, 2007, pp. 456-461; U.S. Pat. No. 9,036,018 to Wang et al.;U.S. Pat. No. 8,488,023 to Bacivarov et al., and U.S. Patent ApplicationPublication 2004/0207720 to Miyahara et al., each of which isincorporated herein by reference.

In an aspect, image processing circuitry 3408 includes physiologicalcondition module 3456, which determines a physiological condition of theuser from user image 3412, based upon one or more parameter 3416.Physiological condition of the user can be inferred from eye movement,pupil dilation, heart rate, respiration rate, facial coloration, facialtemperature, etc. A visible or IR image of the patient, obtained with acamera built into a personal computing device or operatively connectedto the personal computing device can be used. Still or moving (video)image may be used. For example, video images of the subject may beanalyzed to determine blood flow using Eulerian video magnification.Further data analysis may be used to determine blood pressure in thesubject. See, e.g., Wu et al., ACM Trans. Graph. 31, 4, Article 65, July2012; (available online at http://doi.acm.org/10.1145/2185520.2185561),which is incorporated herein by reference. An infrared camera may beused to measure corneal temperature (see e.g., Kessel et al.,Investigative Opthalmology and Visual Science 51: 6593-6597, 2010 whichis incorporated herein by reference). An infrared camera with a focalplane array detector, thermal sensitivity ≤0.09 degrees C. and anaccuracy of 0.1 degrees C. is available from Fluke Corp., Everett, Wash.(see e.g., Fluke_Ti25 Datasheet which is incorporated herein byreference).

Peripheral sympathetic responses can be detected through image analysis,as described in IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 56,NO. 2, FEBRUARY 2009 477, Imaging Facial Signs of NeurophysiologicalResponses, Dvijesh Shastri, Associate Member, IEEE, Arcangelo Merla,Member, IEEE, Panagiotis Tsiamyrtzis, and Ioannis Pavlidis, SeniorMember, IEEE, which is incorporated herein by reference. For example,thermal imaging measurements from several different regions of the faceprovide indication of blood flow, sweat gland activation, and breathing,providing information similar to galvanic skin response. In variousaspects, physiological condition module 3456 is used to determine one ormore medical condition, including, for example, muscle spasm, seizure,epilepsy (e.g., seizure, spasm, staring), drowsiness, lethargy, fatigue,pain, fever, hypertension (e.g., sweating, flushing), hypotension,mental state

In an aspect, image processing circuitry 3408 includes identitydetermination module 3458, which determines an identity of the user fromuser image 3412, based upon one or more parameter 3416. For example,systems and algorithms to obtain iris images, identify unique signaturesand rapidly compare key features of iris images to a large database ofiris images are described (see e.g., U.S. Pat. No. 5,572,596 issued toWildes et al. on Nov. 5, 1996 and U.S. Pat. No. 4,641,349 issued to Flomet al. on Feb. 3, 1987 which are incorporated herein by reference). Aniris scanning system which includes a near-infrared (approximately700-900 nm) illumination source, a 1.3 megapixel camera and algorithmsto analyze and compare iris images is available from Bayometric Inc.,San Jose, Calif. (see e.g., the Specification Sheet: “Crossmatch RetinalScan 2 Iris Scanner” which is incorporated herein by reference). Inanother aspect, facial recognition circuitry is used to determine thepresence of the user through facial recognition, e.g., using approachesas described in Wheeler, Frederick W.; Weiss, R. L.; and Tu, Peter H.,“Face Recognition at a Distance System for Surveillance Applications,”Fourth IEEE International Conference on Biometrics: Theory Applicationsand Systems (BTAS), 2010 Page(s): 1-8 (DOI: 10.1109/BTAS.2010.5634523),and Moi Hoon Yap; Ugail, H.; Zwiggelaar, R.; Rajoub, B.; Doherty, V.;Appleyard, S.; and Hurdy, G., “A Short Review of Methods for FaceDetection and Multifractal Analysis,” International Conference onCyberWorlds, 2009. CW '09., Page(s): 231-236 (DOI: 10.1109/CW.2009.47),both of which are incorporated herein by reference. Biometricidentification can also include recognition based on a variety ofphysiological or behavioral characteristics, such as fingerprints,voice, iris, retina, hand geometry, handwriting, keystroke pattern,etc., e.g., as described in Kataria, A. N.; Adhyaru, D. M.; Sharma, A.K.; and Zaveri, T. H., “A Survey of Automated Biometric AuthenticationTechniques” Nirma University International Conference on Engineering(NUiCONE), 2013, Page(s): 1-6 (DOI: 10.1109/NUiCONE.2013.6780190), whichis incorporated herein by reference. U.S. Pat. No. 8,229,178 issued Jul.24, 2012 to Zhang et al., which is incorporated herein by reference,describes a method for acquiring a palm vein image with visible andinfrared light and extracting features from the image for authenticationof individual identity. Biometric identification can be based on imagingof the retina or iris, as described in U.S. Pat. No. 5,572,596 issued toWildes et al. on Nov. 5, 1996 and U.S. Pat. No. 4,641,349 issued to Flomet al. on Feb. 3, 1987, each of which is incorporated herein byreference. Combinations of several types of identity signals can also beused (e.g., speech and video, as described in Aleksic, P. S. andKatsaggelos, A. K. “Audio-Visual Biometrics,” Proceedings of the IEEEVolume: 94, Issue: 11, Page(s): 2025-2044, 2006 (DOI:10.1109/JPROC.2006.886017), which is incorporated herein by reference).

In an aspect, image processing circuitry 3408 includes eye trackingmodule 3460, which determines an eye position or eye movement from userimage 3412, based upon one or more parameter 3416. For example, a gazetracking system for monitoring eye position is available from SeeingMachines Inc., Tucson, Ariz. (see e.g., the Specification Sheet:“faceLAB™ 5 Specifications” which is incorporated herein by reference).Eye position, eye rotation, eye gaze position against screen, pupildiameter and eye vergence distance may be monitored. Eye rotationmeasurements of up to +/−45 degrees around the y-axis and +/−22 degreesaround the x-axis are possible. Typical static accuracy of gazedirection measurement is 0.5-1 degree rotational error. Eye position canbe sensed using a method and system as described in U.S. Pat. No.8,808,195 to Tseng et al., which is incorporated herein by reference, orby other methods described herein or known to those skilled in therelevant art. Eye position may include static or fixed eye position/gazedirection or dynamic eye position/eye movement. In an aspect, eyetracking module 3460 detects pupil diameter. Pupil diameter can bemeasured, for example, by methods as described in U.S. Pat. No.6,162,186 to Scinto et al., which is incorporated herein by reference.

Ear stimulation device control system 3400 may include various othercomponents as described generally elsewhere herein, including, but notlimited to, e.g., communication circuitry 3462, data storage circuitry3464, and reporting circuitry 3466. Similarly, ear stimulation device3432 may include additional components, including but not limited tocommunication circuitry 3468 and stimulator driver circuitry 3470. Inaddition, ear stimulation device 3432 may include or be used incombination with a securing member 3472. In an aspect, the securingmember includes or is a portion of an earpiece.

FIGS. 35A and 35B show examples of user interfaces used in connectionwith an ear stimulation device control system implemented on a personalcomputing device, and in particular illustrate ways in which processingof a user image captured with a user-facing camera is used in control ofthe ear stimulation device. In the example of FIG. 35A, the personalcomputing device is a smart phone 3500 configured with applicationsoftware that notifies the user of improper placement of the earpieces.Detection and notification is performed, e.g. as described in connectionwith FIGS. 30-34. Delivery of text, visible, and audio notifications tothe user (e.g., as in the method of FIG. 33) are illustrated in FIG.35A. In the systems shown in FIGS. 35A and 35B, the ear stimulationdevice itself is not depicted, but it would be connected to smart phone3500, e.g. via an audio jack. Touchscreen 3502 of smart phone 3500functions as a user interface (e.g., user interface 3444 in FIG. 34).User image 3504, captured with user-facing camera 3506 is displayed ontouchscreen 3502. Image analysis of user image 3504 is performed byimage processing circuitry (e.g., image processing circuitry 3408 inFIG. 34), to determine whether the earpiece including the earstimulation device is positioned properly. In an aspect, properpositioning of the ear stimulation device means that the earpiece islocated on the correct ear, and in some cases also means that theearpiece is located in the proper position on the ear. In the example ofFIG. 35A, earpieces 3508 and 3510 in user image 3504 are differentcolors, allowing the two earpieces to be distinguished. Alert symbol3512 (an exclamation point in a circle) notifies the user of an alertmessage, which is delivered via alert text 3514 displayed on touchscreen3502. In this case, alert text 3514 provides the alert message “1.ALERT: STIMULATION BLOCKED! Switch stimulation earpiece to other ear toallow stimulator activation.” An ‘X’ 3516 (or other marker) displayednext to user image 3504 indicates to the user that earpieces 3508 and3510 are positioned incorrectly. An audible notification 3522 (e.g., a‘beep’) delivered by speaker 3520 is also provided to attract the user'sattention to the incorrectly positioned earpieces. A second user image3524, serving as an exemplar depicting correctly placed earpieces, isalso presented on touchscreen 3502. The colors of earpieces in image3524 may be enhanced or highlighted in the image to emphasize theimportance of placing an earpiece of a particular color at a particularear. A check mark 3526 (or other marker) is used to indicate that seconduser image 3524 depicts correct earpiece position. Check mark 3526 maybe animated, e.g. to switch from flashing to solid or change color fromred to green when the user has switched the earpieces to the properpositions. Once the earpieces are properly positioned, the earstimulation device control system, implemented with smart phone 3500,controls the ear stimulation device to deliver a stimulus to the ear ofthe subject, as described elsewhere herein.

As described in connection with FIG. 34, in an aspect ear stimulationdevice control system 3400 includes emotion determination module 3454,physiological condition module 3456, identity determination module 3458and eye tracking module 3460. These modules can be used to determineadditional information about the user on which to base control of theear stimulation device. In FIG. 35B, touchscreen 3502 of smart phone3500 functions as a user interface. User image 3504, captured withuser-facing camera 3506 is displayed on touchscreen 3502. Image analysisof user image 3504 is performed by image processing circuitry 3408 asshown in FIG. 34, to determine the identity of the user, and potentiallyalso the emotion and physiological status of the user, as discussedherein above. After the identity of the user has been determined,user-specific information can be used to determine neural stimulation.For example, stimulus level settings that have been optimized for theuser can be retrieved from memory and used to configure the earstimulation device. In addition, the stimulus delivered with thestimulation device may be adjusted depending upon the mood orphysiological status of the user.

In addition, in an aspect, application software on smart phone 3500prompts the user to enter additional information regarding mood or otherparameters, similar to application software 2908 described in connectionwith FIG. 29. In the example of FIG. 35B, the mood of the subject maynot be readily determined from the relatively neutral expression of theuser in image 3504. However, the application software may prompt theuser to enter to enter information regarding mood or other feelings. Forexample, text prompt 3556 “Good morning, Anna! Are you tired today?”might be followed by additional questions, depending on the user'sresponse, in order to determine how the user is feeling. The use ofapplication software to assess the mood of the user is discussed ingreater detail elsewhere herein.

As discussed herein above, in an aspect, image detection and analysis isused to detect improper placement of one or more earpieces on the ear(s)of a user of a personal computing device. In some aspects, it isdesirable to detect quality of electrical contact between the ear and anelectrode used for delivering electrical stimuli to or sensingelectrical signals from the ear. FIG. 36 is a block diagram depictingneural stimulation system 3600, which includes ear stimulation device3602 and ear stimulation device control system 3604. FIG. 36 depictsfurther aspects of a neural stimulation system 3600 including an earstimulation device control system 3604, used for controlling an earstimulation device 3602 that delivers electrical stimuli via one or moreelectrodes 3606 and 3608. Ear stimulation device control system 3604determines whether the one or more electrodes 3606 and 3608 are in goodelectrical contact with the ear of the user and notifies the user of thestatus of electrodes 3606 and 3608 so that adjustments can be made, asneeded. In addition, delivery of a stimulus via the electrode can beprevented if it is determined that there is not a good electricalcontact between the electrode and the ear. Ear stimulation devicecontrol system 3604 includes a personal computing device 3610 configuredto control delivery, via ear stimulation device 3602, of a stimulus toat least one nerve innervating an ear of a user of personal computingdevice 3610. Ear stimulation device 3602 includes at least one firstelectrode 3606. Personal computing device 3610 includes electricalsignal input circuitry 3612 adapted to receive an electrical signal 3614indicative of electrical contact of the at least one first electrode3606 with the ear of a user of the personal computing device 3610.Personal computing device 3610 includes contact determination circuitry3616 configured to determine whether the at least one first electrode3606 is in good electrical contact with the ear of the user, and neuralstimulus control signal determination circuitry 3620 configured to senda neural stimulus control signal 3622 from personal computing device3610 to ear stimulation device 3602 to prevent delivery of the stimulusif the at least one first electrode 3606 is not in good electricalcontact with the ear of the user. In addition, personal computing device3610 includes notification circuitry 3622 configured to deliver anotification to the user relating to the status of the at least onefirst electrode 3606. Personal computing device 3610 may be, forexample, a phone, watch, wearable device, tablet computer, laptopcomputer, or desktop computer.

In an aspect, ear stimulation device control system 3604 includeshandshake circuitry 3624 adapted to receive a handshake signal 3626 fromear stimulation device control circuitry 3628 associated with earstimulation device 3602. In an aspect, ear stimulation device controlsystem 3604 includes test signal circuitry 3630 configured to deliver anelectrical test signal 3632 via at least one second electrode 3608 ofthe at least one ear stimulation device 3602, and detecting theelectrical signal 3614 via the at least one first electrode 3606responsive to electrical test signal 3632. In an aspect, contactdetermination circuitry 3616 is configured to determine an electricalimpedance between the at least one first electrode 3606 and the at leastone second electrode 3608. In an aspect, contact determination circuitry3616 is configured to determine an amplitude of electrical signal 3614.In an aspect, contact determination circuitry 3616 is configured todetermine a signal-to-noise ratio of electrical signal 3614. In anaspect, contact determination circuitry 3616 is configured to determinea phase shift or frequency content of the electrical signal 3614. Invarious aspects, contact determination circuitry 3616 includes amplitudedetermination module 3634 for determining the amplitude of electricalsignal 3614, signal-to-noise ratio determination module 3636 fordetermining the signal-to-noise ratio of electrical signal 3614, orphase shift/frequency content determination module 3638 for determiningthe phase shift or frequency content of electrical signal 3614.

In an aspect, ear stimulation device 3602 includes earpiece 3640 whichincludes the at least one first electrode 3606. In an aspect,notification circuitry 3622 is configured to instruct the user toreposition earpiece 3640, replace at least a portion of the at least onefirst electrode 3606, clean at least a portion of the at least one firstelectrode 3606, moisten at least a portion of the at least one firstelectrode 3606, or apply gel to at least a portion of the at least onefirst electrode 3606. As discussed herein above, in various aspects, earstimulation device 3602 includes or is used in connection with asecuring member 3642, and may include additional circuitry components asdescribed elsewhere herein, e.g. communication circuitry 3644 andstimulator driver circuitry 3646. In an aspect, notification circuitry3622 is configured to deliver one or more of a text notification, avisible notification, or an audio notification. Neural stimulationsystem 3600 in various aspects includes other components as describedelsewhere herein. For example, in various aspects personal computingdevice 3610 includes user interface 1214 including user input device1362 and user output 1364, including audio output 1366, graphicaldisplay 1368, alphanumeric display 1392, or touchscreen 1394, asdepicted in and described in connection with FIG. 13, for example. Invarious aspects, ear stimulation device control system includes neuralstimulus control signal output 3424, communication circuitry 3462, datastorage circuitry 3464, as in connection with FIG. 34. In variousaspects, neural stimulation system 3600 includes one or more sensor3650, which may include, for example, a neural signal sensor, otherphysiological sensor, an environmental sensor, a motion sensor, alocation sensor, of various types as described in connection with neuralsignal sensor 702 or secondary sensor 750 in FIG. 7. In some aspects,neural stimulation system 3600 includes a secondary stimulator 818, forexample as described in connection with FIG. 7. In some aspects, neuralstimulation system 3600 includes a sound source 856, e.g. as describedin connection with FIG. 7. Notification circuitry 3442 and reportingcircuitry 3466 are as described in connection with FIG. 34. Personalcomputing device 3610 is configured with application software 3650,including but not limited to the various modules described specificallyherein.

FIG. 37 depicted a method of controlling an ear stimulation device witha personal computing device, responsive to detection of contact betweenan electrode and the ear of the user, as described in connection withFIG. 36. As noted above, the personal computing device may be, forexample, a phone, watch, wearable device, tablet computer, laptopcomputer, or desktop computer. Method 3700 includes detecting atelectrical signal input circuitry, via at least one first electrode ofan earpiece of an ear stimulation device, an electrical signalindicative of electrical contact of the at least one first electrodewith the ear of a user of a personal computing device, wherein the atleast one earpiece is operably connected to the personal computingdevice, and wherein the ear stimulation device is adapted to stimulateat least one nerve innervating the ear of the user of the personalcomputing device, as indicated at 3702; determining, using contactdetermination circuitry on the personal computing device, whether the atleast one first electrode is in good electrical contact with the ear ofthe user, as indicated at 3704; if the at least one first electrode isnot in good electrical contact with the ear of the user, sending acontrol signal from the personal computing device to the ear stimulationdevice, under control of neural stimulus control signal determinationcircuitry on the personal computing device, to prevent delivery via theearpiece of a stimulus to the ear at which the earpiece is located, asindicated at 3706; and delivering, under control of notificationcircuitry on the personal computing device, a notification to the userrelating to the status of the at least one first electrode, as indicatedat 3708.

Determining whether the at least one first electrode is in goodelectrical contact with the ear of the user can be performed by variousmethods, as discussed herein below. Good electrical contact can bedefined by setting a threshold value for one or more measured parameter,such that contact is defined to be “good” if the measured parameter(s)are at or above the threshold value and “bad” if they are below thethreshold parameter. In an aspect, determining whether the at least onefirst electrode is in good electrical contact includes providing arating of the contact quality, e.g., “strong,” “moderate,” “usable butweak,” “unusable,” wherein any usable contact qualities are considered“good,” but contacts that are not usable are considered “bad.”

Further aspects and variants of method 3700 are depicted in FIGS. 38-39.In these figures, steps 3702, 3704, 3706, and 3708 are the same as inFIG. 37.

FIG. 38 depicts a method 3800, which includes further elaborations ofthe method of FIG. 37. Steps 3702, 3704, 3706 and 3708 are as describedin connection with FIG. 37. In an aspect, method 3800 includesreceiving, at handshake circuitry on the personal computing device, ahandshake signal from ear stimulation device control circuitryassociated with the ear stimulation device, as indicated at 3802. Inanother aspect, method 3800 includes delivering, under control of testsignal circuitry on the personal computing device, an electrical testsignal via at least one second electrode of the at least one earpiece,and detecting the electrical signal via the at least one first electroderesponsive to the electrical test signal, as indicated at 3804. This mayinclude, for example, determining an electrical impedance between the atleast one first electrode and the at least one second electrode, asindicated at 3806. In various aspects, determining whether the at leastone first electrode is in good electrical contact with the ear of theuser (at 3704) includes determining an amplitude of the electricalsignal, as indicated at 3808, determining a signal-to-noise ratio of theelectrical signal, as indicated at 3810, or determining a phase shift orfrequency content of the electrical signal, as indicated at 3812.

FIG. 39 depicts a method 3900, including further variants of the methodshown in FIG. 37, relating to delivering a notification to the userregarding the status of the at least one first electrode. In variousaspects, delivering the notification to the user includes instructingthe user to reposition the earpiece, as indicated at 3902, instructingthe user to replace at least a portion of the at least one firstelectrode, as indicated at 3904, instructing the user to clean at leasta portion of the at least one first electrode, as indicated at 3906,instructing the user to moisten at least a portion of the at least onefirst electrode, as indicated at 3908, or instructing the user to applygel to at least a portion of the at least one first electrode, asindicated at 3910. In other aspects, delivering the notification to theuser includes delivering a text notification, as indicated at 3912,delivering a visible notification, as indicated at 3914, delivering anaudio notification, as indicated at 3916, or delivering a directionalnotification, at 3918. Notifications can be delivered, for example, asdescribed in connection with FIG. 31, or as illustrated in FIG. 35A. Inanother aspect, method 3900 includes delivering, under control of testsignal circuitry on the personal computing device, an audio test signalvia a sound source associated with the at least one earpiece, anddetermining proper placement of the at least one earpiece based uponaudio feedback, as indicated at 3920. In an aspect, audio feedback isdetermined from an audio signal detected from the earpiece, which willvary depending upon the placement of the earpiece, e.g. whether or notit is firmly seated within the ear canal. In an aspect, audio feedbackis determined from the user, e.g. the user self-reporting of audioquality.

FIG. 40 illustrates a nerve stimulation system 4000 including earstimulation device 4002 and personal computing device 4004, which isconfigured personal computing device application 4006 for monitoring useof nerve stimulation system 4000 by a user. As in other examplespresented herein, personal computing device 4004 may be, for example aphone, watch, wearable device, tablet computer, laptop computer, ordesktop computer. Aspects of nerve stimulation system 4000 not describedin detail in connection with FIG. 40 are generally as described inconnection with other embodiment depicted and described herein.

Personal computing device application 4006 includes audio deliverymodule 4010, mood assessment module 4012, secondary factor input module4014, user control module 4016, stimulator control module 4018, andcontroller interface module 4020. The various modules includeapplication software operating in connection with personal computingdevice hardware and software (i.e. the personal computing devicehardware is configured by the application software) to provide themodule functionality. Personal computing device 4006 includes otherhardware and software components as described elsewhere herein as wellas conventional hardware and software components not specificallydescribed herein. The term “module,” as used herein, refers toapplication software operating on and used to configure personalcomputing device hardware to provide specialized circuitry functions ofthe device. In general, a module utilizes and in an aspect can beconsidered to incorporate both data storage circuitry and processingcircuitry of the personal computing device.

Audio delivery module 4010 is adapted to control delivery of an audiosignal from an audio signal source 4022 to an audio earpiece 4024 via anaudio output 4026 of the personal computing device 4004, the audioearpiece 4024 having associated therewith ear stimulation device 4002configured to stimulate a nerve innervating the ear of the user. Audiosignal source 4022 may be, for example an audio player application 4024,a web radio application 4026, a radio receiver 4028, a telephonereceiver 4030, or a hearing aid 4031.

Mood assessment module 4012 is adapted to receive mood-related inputfrom the user via a first input structure 4032 associated with thepersonal computing device, and assess a mood of the user based at leastin part upon the mood-related input. In an aspect, mood assessmentmodule 4012 includes an ecological momentary assessment module 4034.Ecological momentary assessment module 4034 includes applicationsoftware on the person computing device that collects information aboutthe user's behaviors and experiences from the user, by querying the userat intervals during the day as they go about their usual activities intheir “natural environment” (as contrasted to self-reports of mood basedon the user's recollections during a clinic visit, for example), e.g. asdescribed generally in Shiffman et al., “Ecological MomentaryAssessment,” Annual Review of Clinical Psychology, Vol. 4:1-32, April2008 (First Published Online Nov. 28, 2007), DOI:10.1146/annurev.clinpsy.3.022806.091415, which is incorporated herein byreference. In some aspects, mood assessment module 4012 includesactivity assessment module 4035, which tracks and analyzes useractivities involving use of the personal computing device (e.g. use ofsocial media, web searches, speech patterns, typing patterns, includingamount and/or type of use) to determine mood of the user. For example,in an aspect, activity assessment module 4035 analyzes typing patternsusing, for example, techniques as described in U.S. Pat. No. 6,231,344to Merzenich et al., U.S. Published Patent Application 2005/0084832 toJanssen et al., each of which is incorporated herein by reference. In anaspect, activity assessment module 4035 determines the timing of entryof instructions by the patient. In an aspect, it is not necessary todetermine the specific instructions entered by the patient, but only todetermine how often the patient is using the personal computing device,and/or how quickly the patient is entering instructions into thepersonal computing device. In other aspects, the specific instructionscan be detected, e.g., to determine whether the patient is choosing tolisten to music, play a game, send or read email, receive a phone call,or place a phone call. Sensing and processing of game controllersignals, e.g., to determine reaction times, may be substantially asdescribed in U.S. Pat. No. 5,913,310 to Brown, or U.S. Pat. No.6,186,145 to Brown, both of which are incorporated herein by reference.It will be appreciated that while Brown describes a video game designedprimarily for health care-related teaching purposes, the video game maybe for entertainment purposes, and need not include an educational ormedical component. In an aspect, activity assessment module 4035 isconfigured to process an audio signal (detected from a cell phone, forexample) to determine a speech pattern of the patient. In an aspect,mood assessment module 4012 includes image processing module 4036adapted to determine a mood of the user based on image analysis of animage of the user detected with a user-facing camera 4038 of thepersonal computing device 4004, e.g., as discussed herein above. Invarious aspects, mood assessment module 4012 is adapted to receivemood-related input relating to depression, stress, or emotion, forexample. First input structure 4032 of the personal computing device invarious aspects includes a touch screen 4040, a keyboard, or amicrophone.

Secondary factor input module 4014 is adapted to receive at least oneinput relating to at least one secondary factor relating to the user viaa second input structure 4050 associated with personal computing device4004. Secondary input structure 4050 of personal computing device 4004includes at least one of a touch screen 4040, a keyboard 4042, amicrophone 4044, a device interface 4052, a data input 4054, USB port4056, a wireless interface 4058, a serial port 4060, and a parallel port4062. Touch screen 4040, a keyboard 4042, a microphone 4044, areexamples of components of a user interface 4064, although it will beappreciated that input may be received by other types of user interfacedevices, as are known to those of skill in the art. Data input 4054, USBport 4056, wireless interface 4058, serial port 4060, and parallel port4062 are examples of device interface 4052; other device interfaces maybe used as well. First input structure 4032, second input structure4050, and third input structure 4066 may in some aspects be the sametype of input structure, and indeed may be the same input structure. Inother aspects, one or more of first input structure 4032, second inputstructure 4050, and third input structure 4066 are the same type ofinput structure, but are distinct input structures. In some aspects,first input structure 4032, second input structure 4050, and third inputstructure 4066, are different types of input structures, and, inaddition, are distinct input structures.

In an aspect, secondary factor input module 4014 is adapted to receiveat least one input from the user, i.e., via user interface 4064. Inanother aspect, secondary factor input module is adapted to receive atleast one input from a sensor 4068, e.g., via data input 4054 or anotherdevice interface. In another aspect, secondary factor input module 4014is adapted to receive at least one input via a computing network 4070.

User control module 4016 is adapted to receive at least one user controlinput via a third input structure 4066 of the personal computing device,the user control input for controlling user-controllable stimulationparameters of the ear stimulation device.

Stimulator control module 4018 is adapted to determine at least onestimulus control parameter based on at least one of the mood of theuser, the at least one secondary factor, and the at least one usercontrol input.

Controller interface module 4020 is used for communicating the at leastone stimulus control parameter to a stimulator controller adapted tocontrol the ear stimulation device responsive to the at least onestimulus control parameter.

In an aspect, stimulator control module 4018 is configured to coordinatedelivery of the audio signal with delivery of at least one stimulus withear stimulation device 4002.

In an aspect, secondary factor input module 4014 is adapted to receiveat least one input relating to an environmental condition of the user,for example, including at least one of a light level, a temperature, ahumidity, a pollen count, a noise level, a day length, a precipitation,an air quality measure. In another aspect, secondary factor input module4014 is adapted to receive at least one input relating to sleep patternof the user. In another aspect, secondary factor input module 4014 isadapted to receive at least one input relating to medical history of theuser. In another aspect, secondary factor input module 4014 is adaptedto receive at least one input relating to an activity of the user,including, but not limited to a physical activity, a health-relatedactivity, a recreational activity, a social activity, an employmentactivity, a purchasing activity, a mental activity, a spiritualactivity, a media-related activity, an activity of daily life, an amountof activity, a duration of activity, a frequency of activity, a timingof activity, a calendar, a schedule, or a cost. In another aspect,secondary factor input module 4014 is adapted to receive at least oneinput relating to a diet of the user or an appetite of the user. Aninput relating to a secondary factor may include user input relating tothe secondary factor, received for example, via user interface 4064. Inan aspect, secondary factor input module 4014 is adapted to receive atleast one open ended comment from the user, e.g. via text input 4074. Inanother aspect, secondary factor input module 4014 is adapted to providea drop down menu 4076 of selectable items and receive from the user aselection from the drop down menu. For example, in an aspect, the menuof selectable items includes topic areas for discussion with a medicalcare provider. In addition to text inputs or menus, various types ofinput elements may be utilized to receive input from the user, voice totext conversion, screen elements with clickable buttons or checkboxesthat allow the user to select from multiple options, sliders that allowthe user to increase or decrease a parameter value between minimum andmaximum values, and various other types of input elements.

In an aspect, personal computing device application 4006 includes arecommendation delivery module 4078, which is configured to present arecommendation to the user. For example, the recommendation can bepresented to the user via user interface 4064, or audio output 4026, orsent to a remote device via device interface 4052, computing network4070, or communication network 4080. In an aspect, recommendationdelivery module 4078 is adapted to receive the recommendation from amedical care provider, from an insurance company, a service provider, anadvisor, a computation-based system, or a social media source. Forexample, in an aspect recommendation delivery module 4078 is adapted toreceive a recommendation via computing network 4070. For example, in anaspect the recommendation based on patients similar to the user. In anaspect, recommendation delivery module 4078 is adapted to generate therecommendation.

In an aspect, personal computing device application 4006 includes acorrelation module 4082 configured to determine at least one correlationbetween the mood of the user and at least one of the at least onesecondary factor and the at least one stimulus control parameter, andrecommendation delivery module is configured to generate therecommendation based at least in part on the at least one correlation.For example, if it is determined that a particular secondary factor(e.g., rainy weather) is normally followed by a depressed mood in theuser, if occurrence of the secondary factor is detected, arecommendation is generated for increasing stimulation. As anotherexample, if a particular activity of the user is correlated withdepression (for example, if the user reports being depressed afterstaying up late and not getting enough sleep, the recommendation mightbe to go to bed earlier).

In an aspect, recommendation delivery module 4078 is adapted to providethe recommendation to a medical care provider of the user. This can bedone, for example, by sending the recommendation to a remote device usedby the medical care provider, via computing network 4070, communicationnetwork 4080, device interface 4052, or via user interface 4064.Providing the recommendation to the medical care provider makes itpossible for the medical care provider to discuss the recommendationwith the user, or not, as deemed appropriate by the medical careprovider, as well as to incorporate the recommendation into an overalltreatment plan for the user.

In an aspect, recommendation delivery module 4078 is configured togenerate the recommendation based on at least one of informationregarding a response of the subject to a past treatment regimen,information obtained via social media, information regarding at leastone preference of at least one social media contact of the subject,information regarding at least one preference of at least one peer ofthe subject, information regarding at least one preference of at leastone role model of the subject, information from an insurance company,information from a service provider.

In an aspect, recommendation delivery module 4078 is configured togenerate the recommendation with a computation-based system; forexample, an artificial intelligence, a neural network, or a machinelearning system. In an aspect, recommendation delivery module 4078 isconfigured to generate the recommendation based on a predicted responseof the subject to a treatment regimen.

In another aspect, recommendation delivery module 4078 is configured toreceive information regarding whether the subject has accepted orrejected the recommendation. In various aspects, recommendation deliverymodule 4078 is configured to present to the user a recommendation for aconfiguration of the neural stimulus, or a recommendation for asecondary stimulus to be delivered in association with the neuralstimulus.

In an aspect, personal computing device application 4006 includesphysiological data module 4084 adapted to receive at least onephysiological data signal representing at least one physiologicalparameter of the user. In an aspect, physiological data module 4084 isadapted to receive the at least one physiological data signal from atleast one sensor 4068. In another aspect, physiological data module 4084is adapted to receive the at least one physiological data signal from atleast one computing network 4070, or alternatively, via at least onecommunication network 4080. In another aspect, physiological data module4084 is adapted to receive the at least one physiological data signalfrom at least one remote sensing system 4086. A remote sensing systemmay include one or more sensors in the environment of the user,including but not limited to cameras, motion sensors, pressure sensors,force sensors, infrared sensors, etc. In various aspects, physiologicaldata module 4084 is adapted to receive the at least one physiologicaldata signal from at least one of a blood pressure sensor, a heart ratesensor, a chemical sensor, a biosensor, a pH sensor, a blood oxygensensor, a galvanic skin response sensor, an EEG sensor, an EMG sensor,an ECG sensor, a wearable item, an eye tracking system, an acousticsensor, a motion sensor, a force transducer, or an activity sensor.

In an aspect, user control module 4016 is adapted to receive user input(e.g., via user interface 4064) for controlling at least one of stimuluspulse amplitude, stimulus pulse duration, stimulus frequency, stimuluspulse pattern, and stimulus pulse envelope.

In an aspect, personal computing device application 4006 includesexternal control module 4088, which is configured to receive an externalcontrol input for controlling at least one externally controllablestimulation parameter of the ear stimulation device. For example, invarious aspects, external control module 4088 is configured to receivethe external control input via computing network 4070 or communicationnetwork 4080. In an aspect, external control module 4088 is configuredto receive the external control input from an external party or entity.In an aspect, the external party or entity is a medical care provider.In other aspects, the external control input may be received from otherexternal parties or entities, e.g., a family member, an insurancecompany, the device manufacturer, etc. The at least one externallycontrollable stimulation parameter includes, for example, at least oneof stimulus pulse amplitude, stimulus pulse duration, stimulusfrequency, stimulus pulse pattern, and stimulus pulse envelope.Externally controllable stimulation parameters may include preferredvalues for efficacy of treatment, including preferred values to be usedin connection with different patent conditions, or upper and lowerlimits for stimulus values, for purposes of patient safety or efficacyof treatment.

In another aspect, personal computing device application 4006 includesdata transfer module 4090 for providing data relating to the user to anexternal party or entity. In an aspect, data transfer module 4090 isconfigured to provide the data to the external party or entity viacomputing network 4070. In another aspect, data transfer module isconfigured to provide the data to the external party or entity viacommunication network 4080. For example, the external party or entitymay be a medical care provider, a family member, an insurance company, aservice provider, a social media contact (or ‘friend’) of the subject, apeer of the subject, an advisor, a computation based system, a socialmedia source, a device manufacturer, a merchant, an electronic medicalrecord, a sensor network, or an additional program or application, forexample. In an aspect, a sensor network includes or is part of a healthdiary platform, a smart home, or an internet of things.

In an aspect, stimulator control module 4018 is configured to determinethe at least one stimulus control parameter 4034 by overriding the atleast one user control input for controlling the at least oneuser-controllable stimulation parameter based on a medical-care providercontrol input. Alternatively, in another aspect, stimulator controlmodule 4018 is configured to override a medical-care provider controlinput based on the at least one user control input for controlling theat least one user-controllable stimulation parameter. In yet anotheraspect, stimulator control module 4018 is configured to override the atleast one user control input for controlling the at least oneuser-controllable stimulation parameter based on a computingsystem-generated stimulus control parameter. In another aspect,stimulator control module 4018 is configured to override a computingsystem-generated stimulus control parameter based on the at least oneuser control input for controlling the at least one user-controllablestimulation parameter. For example, stimulator control module 4018 isconfigured to determine the at least one stimulus control parameter toprovide an initial setting of the ear stimulation device based on the atleast one user-controllable stimulation parameter. In another aspect,stimulator control module 4018 is configured to determine the at leastone stimulus control parameter to update a setting of the earstimulation device based on the at least one user-controllablestimulation parameter.

FIG. 41 is a flow diagram of a method of controlling an ear stimulationdevice with a personal computing device. Method 4100 may be performed,for example, using a personal computing device configured withapplication software, as depicted and discussed in connection with FIG.40. Method 4100 includes receiving an audio signal at the personalcomputing device from an audio signal source, as indicated at 4102;delivering the audio signal to an audio earpiece worn by a user via anaudio output of the personal computing device, the audio earpiece havingassociated therewith an ear stimulation device configured to stimulate anerve innervating the ear of the user, as indicated at 4104; receivingwith a mood assessment module, via a first input structure associatedwith the personal computing device, a mood-related input from the user,as indicated at 4106; assessing, with the mood assessment module, a moodof the user based at least in part upon the mood-related input, asindicated at 4108; receiving with a secondary factor input module, via asecond input structure associated with the personal computing device, atleast one input relating to at least one secondary factor relating tothe user, as indicated at 4110; receiving with a user control module,via a third input structure associated with the personal computingdevice, at least one user control input for controlling at least oneuser-controllable stimulation parameter of the ear stimulation device,as indicated at 4112; determining, with a stimulator control module, atleast one stimulus control parameter based on at least one of the moodof the user, the at least one secondary factor, and the at least oneuser control input, as indicated at 4114; and communicating, with acontroller interface module, at least one stimulus control parameter toa stimulator controller, the stimulator controller adapted to controlthe ear stimulation device responsive to the at least one stimuluscontrol parameter, as indicated at 4116.

Further aspects of the method shown in FIG. 41 are shown in FIGS. 42-47.

For example, as shown in FIG. 42, in various aspects of a method 4200,receiving the audio signal at the personal computing device from theaudio signal source includes receiving the audio signal from an audioplayer application, as indicated at 4202; receiving the audio signalfrom a web radio application, as indicated at 4204; receiving the audiosignal from a radio receiver, as indicated at 4206, receiving the audiosignal from a telephone receiver, as indicated at 4208, or receiving theaudio signal from a hearing aid, as indicated at 4210.

Receiving the mood-related input in various aspects includes receivinguser input via an ecological momentary assessment module, as indicatedat 4212; receiving an image of the user with a user-facing camera of thepersonal computing device, and determining a mood of the user based onimage analysis of the image of the user with image processing softwareof the mood assessment module, as indicated at 4214. Mood assessmentbased on image analysis is discussed in greater detail herein above.Receiving the mood-related input may include receiving mood-relatedinput relating to one or more of depression, as indicated at 4216;stress, as indicated at 4218; emotion, as indicated at 4220; or a mentaldisorder, as indicated at 4222. In an aspect, receiving the mood-relatedinput via the first input structure includes receiving at least oneinput via a touch screen, a keyboard, or a microphone, as indicated at4224. In an aspect, method 4200 includes coordinating, with thestimulator control module, delivery of the audio signal with delivery ofat least one stimulus with the ear stimulation device, as indicated at4224.

FIG. 43 provides further variants of the method of FIG. 41, relating toreceiving at least one input relating to at least one secondary factorrelating to the user, at 4110. In an aspect of method 4300, receivingthe at least one input relating to the at least one secondary factorincludes receiving at least one input via at least one of a touchscreen, a keyboard, a microphone, a device interface, a data input, aUSB port, a wireless interface, a serial port, and a parallel port, asindicated at 4302. In further aspects, receiving at least one inputrelating to at least one secondary factor relating to the user with thesecondary factor input module includes receiving at least one input fromthe user, as indicated at 4304; receiving at least one input from asensor, as indicated at 4306; or receiving at least one input via acomputing network, as indicated at 4308.

In another aspect, receiving at least one input relating to at least onesecondary factor relating to the user with the secondary factor inputmodule includes receiving at least one input relating to anenvironmental condition of the user, as indicated at 4310. Anenvironmental condition may include, for example, at least one of alight level, a temperature, a humidity, a pollen count, a noise level, aday length, a precipitation, an air quality measure, as indicated at4312.

In other aspects, receiving at least one input relating to at least onesecondary factor relating to the user with the secondary factor inputmodule includes receiving at least one input relating to a sleep patternof the user, as indicated at 4314; a medical history of the user, asindicated at 4315; a diet of the user, as indicated at 4316; an appetiteof the user, as indicated at 4318; or an activity of the user, asindicated at 4320. For example, receiving at least one input relating toan activity includes receiving at least one input relating to, e.g., aphysical activity, a recreational activity, a social activity, anemployment activity, a purchasing activity, a mental activity, aspiritual activity, a media-related activity, an activity of daily life,an amount of activity, a duration of activity, a frequency of activity,a timing of activity, a calendar, a schedule, or a cost, as indicated at4322.

In further aspect, receiving at least one input relating to at least onesecondary factor relating to the user with the secondary factor inputmodule includes receiving at least one open ended comment from the user,as indicated at 4324. In other aspects, receiving at least one inputrelating to at least one secondary factor relating to the user with thesecondary factor input module includes providing a drop down menu ofselectable items and receiving from the user a selection from the dropdown menu, as indicated at 4326. For example, in an aspect, providing adrop down menu of selectable items includes providing a drop down menuof selectable topic areas for discussion with medical care provider, asindicated at 4328.

As shown in FIG. 44, in an aspect a method 4400 includes presenting arecommendation to the user with a recommendation delivery module, asindicated at 4402. The recommendation may be received from a medicalcare provider, from an insurance company, a service provider, anadvisor, a computation-based system, or a social media source, asindicated at 4404, or from a computing network, as indicated at 4406. Inanother aspect, method 4400 includes providing the recommendation to amedical care provider of the user with the recommendation deliverymodule, as indicated at 4408. In a further aspect, method 4400 includesreceiving, with the recommendation delivery module, informationregarding whether the subject has accepted or rejected therecommendation, as indicated at 4410.

In various aspects, presenting the recommendation includes presenting arecommendation for a configuration of the neural stimulus, as indicatedat 4412, or presenting a recommendation for a secondary stimulus to bedelivered in association with the neural stimulus, as indicated at 4414.

In an aspect, method 4400 includes delivering a recommendation based onpatients similar to the user, as indicated at 4416.

In an aspect, method 4400 includes generating the recommendation withthe recommendation delivery module, as indicated at 4418. For example,the method may include determining, with a correlation module, at leastone correlation between the mood of the user and at least one of the atleast one secondary factor and the at least one stimulus controlparameter, and generating the recommendation with the recommendationdelivery module based at least in part on the at least one correlation,as indicated at 4420. In an aspect, the method includes generating therecommendation based on at least one of information regarding a responseof the subject to a past treatment regimen, information obtained viasocial media, information regarding at least one preference of at leastone social media contact of the subject, information regarding at leastone preference of at least one peer of the subject, informationregarding at least one preference of at least one role model of thesubject, information from an insurance company, information from aservice provider, as indicated at 4422. In some aspects, the methodincludes generating the recommendation with a computation-based system,as indicated at 4424, or generating the recommendation based on apredicted response of the subject to a treatment regimen, as indicatedat 4426.

FIG. 45 depicts aspects of a related method 4500. In an aspect, method4500 includes receiving, with a physiological data module, at least onephysiological data signal representing at least one physiologicalparameter of the user, as indicated at 4502. Receiving the at least onephysiological data signal includes, for example, receiving the at leastone physiological data signal from at least one sensor, as indicated at4504. In an aspect, the at least one sensor is located on the audioearpiece associated with the ear stimulation device, as indicated at4506. In an aspect, the audio earpiece having the ear stimulation deviceassociated therewith is a first audio earpiece worn on a first ear ofthe subject, and wherein the at least one sensor is located on a secondaudio earpiece located on a second ear of the subject, as indicated at4508.

In an aspect, receiving the at least one physiological data signalincludes receiving the at least one physiological data signal from atleast one computing network, as indicated at 4510, or from at least oneremote sensing system, as indicated at 4512. In various aspects,receiving the at least one physiological data signal includes receivingthe at least one physiological data signal from at least one of a bloodpressure sensor, a heart rate sensor, a chemical sensor, a biosensor, apH sensor, a blood oxygen sensor, a galvanic skin response sensor, anEEG sensor, an EMG sensor, an ECG sensor, a wearable item, an eyetracking system, an acoustic sensor, a motion sensor, a forcetransducer, or an activity sensor, as indicated at 4514.

In a further aspect, method 4500 includes providing data relating to theuser to an external party or entity, as indicated at 4516. In variousaspects, providing the data to the external party or entity includesproviding the data via a computing network, as indicated at 4518, orproviding the data via a communication network, as indicated at 4520. Inan aspect, providing the data to the external party or entity includesproviding the data to a medical care provider, as indicated at 5422. Invarious aspects, providing the data to the external party or entityincludes providing the data to a family member, an insurance company, aservice provider, a social media contact of the subject, a peer of thesubject, an advisor, a computation based system, a social media source,a device manufacturer, a merchant, an electronic medical record, asensor network, a program or an application, as indicated at 4524.

FIG. 46 depicts further aspects of a method 4600. In one aspect ofmethod 4600, receiving the at least one user control input forcontrolling the at least one user-controllable stimulation parameterincludes receiving at least one user input for controlling at least oneof stimulus pulse amplitude, stimulus pulse duration, stimulusfrequency, stimulus pulse pattern, and stimulus pulse envelope, asindicated at 4602.

In another aspect, method 4600 includes determining, with a correlationmodule, at least one correlation between the mood of the user and atleast one of the at least one secondary factor and the at least onestimulus control parameter, as indicated at 4604.

In another aspect, method 4600 includes receiving, with an externalcontrol module, an external control input for controlling at least oneexternally controllable stimulation parameter of the ear stimulationdevice, as indicated at 4606. In various aspects, this includesreceiving the external control input via a computing network or acommunication network, as indicated at 4608. In an aspect, receiving theexternal control input includes receiving the external control inputfrom an external party or entity, as indicated at 4610, for example, amedical care provider, as indicated at 4612, or a family member, aninsurance company, a service provider, a social media contact of thesubject, a peer of the subject, an advisor, a computation based system,a social media source, a device manufacturer, a merchant, an electronicmedical record, a sensor network, a program or an application, asindicated at 4614. In various aspect, the at least one externallycontrollable stimulation parameter includes at least one of stimuluspulse amplitude, stimulus pulse duration, stimulus frequency, stimuluspulse pattern, and stimulus pulse envelope, as indicated at 4616.

FIG. 47 depicts further aspects of a method 4700, relating todetermining the at least one stimulus control parameter. In an aspect,determining the at least one stimulus control parameter includesoverriding the at least one user control input for controlling the atleast one user-controllable stimulation parameter based on amedical-care provider control input, as indicated at 4702. In anotheraspect, determining the at least one stimulus control parameter includesoverriding a medical-care provider control input based on the at leastone user control input for controlling the at least oneuser-controllable stimulation parameter, as indicated at 4704. In yetanother aspect, determining the at least one stimulus control parameterincludes overriding the at least one user control input for controllingthe at least one user-controllable stimulation parameter based on acomputing system-generated stimulus control parameter, as indicated at4706. In still another aspect, determining the at least one stimuluscontrol parameter includes overriding a computing system-generatedstimulus control parameter based on the at least one user control inputfor controlling the at least one user-controllable stimulationparameter, as indicated at 4708.

In an aspect, determining the at least one stimulus control parameterincludes determining an initial setting of the ear stimulation devicebased on the at least one user-controllable stimulation parameter, asindicated at 4710. In another aspect, determining the at least onestimulus control parameter includes updating a setting of the earstimulation device based on the at least one user-controllablestimulation parameter, as indicated at 4712.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected”, or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components may be referred to herein as“configured to,” “configured by,” “configurable to,” “operable/operativeto,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.Those skilled in the art will recognize that such terms (e.g.,“configured to”) generally encompass active-state components and/orinactive-state components and/or standby-state components, unlesscontext requires otherwise.

A personal computing device, as described herein, may include circuitryand other hardware components, provided, for example in the form of acustom board installed in the case of the personal computing deviceduring or after manufacture, or in a separate package that may beoperably connected to the personal computing device via one or morewired and/or wireless connection. Unless context dictates otherwise, asused herein, the term personal computing device is intended to encompasssystems including circuitry and other hardware components packaged withthe personal computing device and circuitry and other hardwarecomponents packaged separately but used in combination with the personalcomputing device.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

The invention claimed is:
 1. A computer program product comprising: anon-transitory signal-bearing medium bearing: one or more audio deliveryinstructions for controlling delivery of an audio signal from an audiosignal source to an audio earpiece via an audio output of a personalcomputing device, the audio earpiece having operably coupled thereto anear stimulation device configured to stimulate a nerve innervating apinna of an ear of the user; one or more mood assessment instructionsfor receiving mood-related input from the user via a first inputstructure operably coupled to the personal computing device; andassessing a mood of the user based at least in part upon themood-related input; one or more secondary factor input instructions forreceiving at least one input relating to at least one secondary factorrelating to the user via a second input structure operably coupled tothe personal computing device; one or more user control instructions forreceiving via a third input structure of the personal computing device,at least one user control input for controlling at least oneuser-controllable stimulation parameter of the ear stimulation device;one or more stimulator control instructions for determining at least onestimulus control parameter based on at least one of the mood of theuser, the at least one secondary factor, and the at least one usercontrol input; and one or more controller interface instructions forcommunicating the at least one stimulus control parameter to astimulator controller adapted to control the ear stimulation deviceresponsive to the at least one stimulus control parameter.
 2. Thecomputer program product of claim 1, wherein the one or more stimulatorcontrol instructions include one or more instructions for coordinatingdelivery of the audio signal with delivery of at least one stimulus withthe ear stimulation device.
 3. The computer program product of claim 1,wherein the first input structure of the personal computing deviceincludes a touch screen, a keyboard, or a microphone.
 4. The computerprogram product of claim 1, wherein the secondary input structure of thepersonal computing device includes at least one of a touch screen, akeyboard, a microphone, a device interface, a data input, a USB port, awireless interface, a serial port, or a parallel port.
 5. The computerprogram product of claim 1, including one or more recommendationdelivery instructions for presenting a recommendation to the user. 6.The computer program product of claim 5, wherein the one or morerecommendation delivery instructions include one or more instructionsfor generating the recommendation.
 7. The computer program product ofclaim 5, wherein the one or more recommendation delivery instructionsinclude one or more instructions for receiving at least one of arecommendation from a medical care provider, a recommendation from aninsurance company, a recommendation from a service provider, arecommendation from an advisor, a recommendation from acomputation-based system, a recommendation from a social media source, arecommendation via a computing network, a recommendation based onpatients similar to the user, or information regarding whether the userhas accepted or rejected the recommendation.
 8. The computer programproduct of claim 5, wherein the one or more recommendation deliveryinstructions include one or more instructions for generating therecommendation based on at least one of information regarding a responseof the user to a past treatment regimen, information obtained via socialmedia, information regarding at least one preference of at least onesocial media contact of the user, information regarding at least onepreference of at least one peer of the user, information regarding atleast one preference of at least one role model of the user, informationfrom an insurance company, information from a service provider, apredicted response of the user to a treatment regimen, or at least onecorrelation between the mood of the user and at least one of the atleast one secondary factor or the at least one stimulus controlparameter.
 9. The computer program product of claim 5, wherein the oneor more recommendation delivery instructions include one or moreinstructions for presenting to the user at least one of a recommendationfor a configuration of a neural stimulus or a recommendation for asecondary stimulus to be delivered in association with the neuralstimulus.
 10. The computer program product of claim 1, including one ormore physiological data instructions for receiving at least onephysiological data signal including at least one physiological parameterof the user.
 11. The computer program product of claim 10, wherein theone or more physiological data instructions include one or moreinstructions for receiving the at least one physiological data signalfrom at least one of a blood pressure sensor, a heart rate sensor, achemical sensor, a biosensor, a pH sensor, a blood oxygen sensor, agalvanic skin response sensor, an EEG sensor, an EMG sensor, an ECGsensor, a wearable item, an eye tracking system, an acoustic sensor, amotion sensor, a force transducer, or an activity sensor.
 12. Thecomputer program product of claim 10, wherein the one or morephysiological data instructions include one or more instructions forreceiving the at least one physiological data signal from at least oneof at least one sensor, at least one computing network, or at least oneremote sensing system.
 13. The computer program product of claim 1,wherein the one or more user control instructions include one or moreinstructions for receiving user input for controlling at least one ofstimulus pulse amplitude, stimulus pulse duration, stimulus frequency,stimulus pulse pattern, or stimulus pulse envelope.
 14. The computerprogram product of claim 1, including one or more external controlinstructions for receiving an external control input for controlling atleast one externally controllable stimulation parameter of the earstimulation device.
 15. The computer program product of claim 14,wherein the at least one externally controllable stimulation parameterincludes at least one of stimulus pulse amplitude, stimulus pulseduration, stimulus frequency, stimulus pulse pattern, or stimulus pulseenvelope.
 16. The computer program product of claim 14, wherein the oneor more external control instructions include one or more instructionsfor receiving the external control input via a computing network or acommunication network, receiving the external control input from anexternal party or entity, or receiving the external control input from amedical care provider.
 17. The computer program product of claim 1,including at least one of one or more correlation instructions fordetermining at least one correlation between the mood of the user and atleast one of the at least one secondary factor and the at least onestimulus control parameter; or one or morel data transfer instructionsfor providing data relating to the user to an external party or entity.18. The computer program product of claim 1, wherein the audio signalsource includes at least one of an audio player application, a web radioapplication, a radio receiver, a telephone receiver, or a hearing aid.19. The computer program product of claim 1, wherein the one or moremood assessment instructions includes at least one of one or moreecological momentary assessment instructions, one or more activityassessment instructions, or one or more image processing instructionsfor determining a mood of the user based on image analysis of an imageof the user detected with a user-facing camera of the personal computingdevice.
 20. The computer program product of claim 1, wherein the one ormore secondary factor input instructions include one or moreinstructions for receiving at least one of an input from the user, aninput from a sensor, or an input via a computing network.
 21. Thecomputer program product of claim 1, wherein the one or more secondaryfactor input instructions include one or more instructions for receivingat least one of an input relating to an environmental condition of theuser, an input relating to a sleep pattern of the user, an inputrelating to a medical history of the user, an input relating to anactivity of the user, an input relating to a diet of the user, or aninput relating to an appetite of the user.
 22. The computer programproduct of claim 1, wherein the one or more secondary factor inputinstructions include one or more instructions for receiving at least oneopen ended comment from the user or to provide a drop down menu ofselectable items and receive from the user a selection from the dropdown menu.
 23. The computer program product of claim 17, wherein the oneor more data transfer instructions include one or more instructions forproviding the data to the external party or entity via at least one of acomputing network or a communication network.
 24. The computer programproduct of claim 1, wherein the one or more stimulator controlinstructions include one or more instructions for determining the atleast one stimulus control parameter by overriding the at least one usercontrol input for controlling the at least one user-controllablestimulation parameter based on a medical-care provider control input;overriding a medical-care provider control input based on the at leastone user control input for controlling the at least oneuser-controllable stimulation parameter; overriding the at least oneuser control input for controlling the at least one user-controllablestimulation parameter based on a computing system-generated stimuluscontrol parameter; or overriding a computing system-generated stimuluscontrol parameter based on the at least one user control input forcontrolling the at least one user-controllable stimulation parameter.25. The computer program product of claim 1, wherein the one or morestimulator control instructions include one or more instructions fordetermining the at least one stimulus control parameter to provide aninitial setting of the ear stimulation device based on the at least oneuser-controllable stimulation parameter or to update a setting of theear stimulation device based on the at least one user-controllablestimulation parameter.
 26. A method of controlling an ear stimulationdevice with a personal computing device, comprising: receiving an audiosignal at the personal computing device from an audio signal source;delivering the audio signal to an audio earpiece worn by a user via anaudio output of the personal computing device, the audio earpiece havingoperably coupled thereto an ear stimulation device configured tostimulate a nerve innervating a pinna of an ear of the user; receiving,via a first input structure operably coupled to the personal computingdevice, a mood-related input from the user; assessing a mood of the userbased at least in part upon the mood-related input; receiving, via asecond input structure operably coupled to the personal computingdevice, at least one input relating to at least one secondary factorrelating to the user; receiving, via a third input structure operablycoupled to the personal computing device, at least one user controlinput for controlling at least one user-controllable stimulationparameter of the ear stimulation device; determining at least onestimulus control parameter based on at least one of the mood of theuser, the at least one secondary factor, and the at least one usercontrol input; and communicating at least one stimulus control parameterto a stimulator controller, the stimulator controller adapted to controlthe ear stimulation device responsive to the at least one stimuluscontrol parameter.
 27. The method of claim 26, including coordinatingdelivery of the audio signal with delivery of at least one stimulus withthe ear stimulation device.
 28. The method of claim 26, includingpresenting a recommendation to the user.
 29. The method of claim 28,including receiving the recommendation from at least one of an externalparty, an external entity, an insurance company, a service provider, anadvisor, a computation-based system, a social media source, or acomputing network.
 30. The method of claim 28, including at least one ofdelivering the recommendation based on patients similar to the user;generating the recommendation; providing the recommendation to anexternal party or entity; or receiving information regarding whether theuser has accepted or rejected the recommendation.
 31. The method ofclaim 28, including at least one of generating the recommendation modulebased at least in part on at least one correlation between the mood ofthe user and at least one of the at least one secondary factor or the atleast one stimulus control parameter; generating the recommendationbased on at least one of information regarding a response of the user toa past treatment regimen, information obtained via social media,information regarding at least one preference of at least one socialmedia contact of the user, information regarding at least one preferenceof at least one peer of the user, information regarding at least onepreference of at least one role model of the user, information from aninsurance company, or information from a service provider; generatingthe recommendation with a computation-based system; or generating therecommendation based on a predicted response of the user to a treatmentregimen.
 32. The method of claim 28, wherein presenting therecommendation includes at least one of presenting the recommendationfor a configuration of a neural stimulus or presenting a recommendationfor a secondary stimulus to be delivered in association with the neuralstimulus.
 33. The method of claim 26, including receiving at least onephysiological data signal including at least one physiological parameterof the user.
 34. The method of claim 33, wherein receiving the at leastone physiological data signal includes at least one of receiving the atleast one physiological data signal from a sensor; receiving the atleast one physiological data signal from a sensor located on the audioearpiece operably coupled to the ear stimulation device; receiving theat least one physiological data signal from a sensor located on a secondaudio earpiece located on a second ear of the user, wherein the audioearpiece having the ear stimulation device operably coupled thereto is afirst audio earpiece worn on a first ear of the user; receiving the atleast one physiological data signal from at least one computing network;receiving the at least one physiological data signal from at least oneremote sensing system; or receiving the at least one physiological datasignal from at least one of a blood pressure sensor, a heart ratesensor, a chemical sensor, a biosensor, a pH sensor, a blood oxygensensor, a galvanic skin response sensor, an EEG sensor, an EMG sensor,an ECG sensor, a wearable item, an eye tracking system, an acousticsensor, a motion sensor, a force transducer, or an activity sensor. 35.The method of claim 26, wherein receiving the at least one user controlinput for controlling the at least one user-controllable stimulationparameter includes receiving at least one user input for controlling atleast one of stimulus pulse amplitude, stimulus pulse duration, stimulusfrequency, stimulus pulse pattern, or stimulus pulse envelope.
 36. Themethod of claim 26, wherein receiving the audio signal at the personalcomputing device from the audio signal source includes at least one ofreceiving the audio signal from an audio player application, receivingthe audio signal from a web radio application, receiving the audiosignal from a radio receiver, receiving the audio signal from atelephone receiver, or receiving the audio signal from a hearing aid.37. The method of claim 26, wherein receiving the mood-related inputincludes at least one of receiving user input via a user interfacedevice or; receiving an image of the user with a user-facing camera ofthe personal computing device and determining a mood of the user basedon image analysis of the image of the user with image processingsoftware; or receiving at least one input via a touch screen, akeyboard, or a microphone.
 38. The method of claim 26, wherein receivingthe mood-related input includes receiving mood-related input relating toat least one of depression, stress, or emotion.
 39. The method of claim26, wherein receiving the at least one input relating to the at leastone secondary factor includes at least one of receiving at least oneinput via at least one of a touch screen, a keyboard, a microphone, adevice interface, a data input, a USB port, a wireless interface, aserial port, or a parallel port; receiving at least one input from theuser; receiving at least one input from a sensor; receiving at least oneinput via a computing network; receiving at least one input relating toan environmental condition of the user; receiving at least one inputrelating to a sleep pattern of the user; receiving at least one inputrelating to an activity of the user; receiving at least one inputrelating to a diet of the user; receiving at least one input relating toan appetite of the user; receiving at least one open ended comment fromthe user; or providing a drop down menu of selectable items andreceiving from the user a selection from the drop down menu.
 40. Themethod of claim 26, including at least one of determining at least onecorrelation between the mood of the user and at least one of the atleast one secondary factor and the at least one stimulus controlparameter; receiving an external control input for controlling at leastone externally controllable stimulation parameter of the ear stimulationdevice; or providing data relating to the user to an external party orentity.
 41. The method of claim 26, including receiving an externalcontrol input for controlling at least one externally controllablestimulation parameter of the ear stimulation device; wherein receivingthe external control input includes at least one of receiving theexternal control input via a computing network; receiving the externalcontrol input via a communication network; receiving the externalcontrol input from an external party or entity; or receiving theexternal control input from a medical care provider.
 42. The method ofclaim 26, including providing data relating to the user to an externalparty or entity, wherein providing the data to the external party orentity includes at least one of providing the data via a computingnetwork, providing the data via a communication network, or providingthe data to a medical care provider.
 43. The method of claim 26, whereindetermining the at least one stimulus control parameter includes atleast one of overriding the at least one user control input forcontrolling the at least one user-controllable stimulation parameterbased on a medical-care provider control input; overriding amedical-care provider control input based on the at least one usercontrol input for controlling the at least one user-controllablestimulation parameter; overriding the at least one user control inputfor controlling the at least one user-controllable stimulation parameterbased on a computing system-generated stimulus control parameter;overriding a computing system-generated stimulus control parameter basedon the at least one user control input for controlling the at least oneuser-controllable stimulation parameter; determining an initial settingof the ear stimulation device based on the at least oneuser-controllable stimulation parameter; or updating a setting of theear stimulation device based on the at least one user-controllablestimulation parameter.